02/22/2010 |
FDA Approves Once-Daily Pramipexole for Early Parkinson's Disease |
02/22/2010 |
FDA Approves New Meningococcal Disease Vaccine |
02/18/2010 |
FDA Approves Rituximab to Treat Chronic Lymphocytic Leukaemia |
02/17/2010 |
Health Canada Approves Concentrated Version of Alpha1-Proteinase Inhibitor |
02/17/2010 |
NICE Recommends Liraglutide for Diabetes Triple Therapy |
02/11/2010 |
FDA Approves Olmesartan Medoxomil for Hypertension in Children, Adolescents |
02/09/2010 |
Health Canada Approves HPV Vaccine, Types 16 and 18 |
02/09/2010 |
Health Canada Approves Darunavir for Children, Adolescents With HIV |
02/08/2010 |
Rosuvastatin Approved for US Adults With No Clinically Evident Cardiovascular Disease |
02/03/2010 |
US FDA Approves First Nonsurgical Treatment for Adult Dupuytren's Contracture |
02/01/2010 |
FDA Approves Lapatinib/Letrozole for Hormone-Positive, HER2-Positive Advanced Breast Cancer |
02/01/2010 |
FDA Approves Once-Daily Lamotrigine XR for Primary Generalised Tonic-Clonic Seizures |
01/29/2010 |
FDA Warns of Serious Liver Disorder Associated With Use of Didanosine |
01/26/2010 |
FDA Approves Once-Daily Liraglutide Injection for Type 2 Diabetes |
01/24/2010 |
FDA Approves Dalfampridine to Improve Walking in Adults With MS |
01/21/2010 |
FDA Approves Left Ventricular Assist System for Severe Heart Failure Patients |
01/21/2010 |
FDA's Safety Review of Sibutramine Warrants New Contraindication Label |
01/14/2010 |
Health Canada Approves Budesonide/Formoterol Dry Powder Inhaler for COPD |
01/13/2010 |
FDA Approves Plasma Replacement Therapy for von Willebrand Disease |
01/11/2010 |
FDA Approves Tocilizumab for Rheumatoid Arthritis |
01/05/2010 |
Health Canada Approves Imiquimod Cream for Actinic Keratosis |
12/23/2009 |
FDA Approves New Influenza Vaccine Designed Specifically for Older Adults |
12/23/2009 |
FDA's Ongoing Safety Review Shows No Link Between Ezetimibe/Simvastatin, Cancer Risk |
12/22/2009 |
Health Canada Approves 13-Valent Pneumococcal Vaccine |
12/18/2009 |
FDA Approves Tiotropium Bromide Inhalation Powder for Reducing COPD Exacerbation |
12/15/2009 |
Four Lots of H1N1 Vaccine Recalled, Revaccination Not Required |
12/14/2009 |
FDA Approves Long-Acting Olanzapine Intramuscular Injection for Schizophrenia |
12/08/2009 |
FDA Interim Recommendations on Potential Excess Radiation Exposure During CT Scans |
12/02/2009 |
FDA Approves Low-Dose Local Oestrogen Therapy for the Treatment of Atrophic Vaginitis Due to Menopause |
12/02/2009 |
FDA Approves Ecallantide for Treatment of Acute Attacks of Hereditary Angio-Oedema in Patients 16 Years and Older |
11/30/2009 |
FDA Approves Agriflu Seasonal Influenza Vaccine |
11/23/2009 |
FDA Investigates Risk of Cardiovascular Events in Patients Using Sibutramine |
11/20/2009 |
FDA Approves Aripiprazole to Treat Irritability Associated With Autistic Disorder |
11/20/2009 |
FDA Approves Ziprasidone for Adjunctive Maintenance Treatment of Bipolar Disorder |
11/19/2009 |
Lubiprostone Approved in Switzerland for Chronic Idiopathic Constipation |
11/17/2009 |
FDA: Avoid Coadministration of Clopidogrel and Omeprazole, Esomeprazole |
11/16/2009 |
FDA Approves Capsaicin 8% Patch for Treatment of Postherpetic Neuralgia |
11/13/2009 |
FDA Approves Tranexamic Acid Tablets to Treat Menorrhagia |
11/13/2009 |
Health Canada Approves Unadjuvanted H1N1 Vaccine |
11/12/2009 |
FDA Approves H1N1 Vaccines for Children as Young as 6 Months Old |
11/06/2009 |
FDA Approves Romidepsin Injection for Previously Treated T-Cell Lymphoma |
11/02/2009 |
FDA Approves Exenatide as First-Line Treatment for Type 2 Diabetes |
10/27/2009 |
Rilonacept Approved in the EU for Cryopyrin-Associated Periodic Syndromes |
10/27/2009 |
FDA Grants Accelerated Approval to Ofatumumab for Refractory Chronic Lymphocytic Leukaemia |
10/26/2009 |
FDA Authorises Emergency Use of Intravenous Peramivir for Certain Hospitalised Patients With H1N1 Influenza |
10/19/2009 |
FDA Approves Pazopanib for Advanced Renal Cell Carcinoma |
10/19/2009 |
FDA Approves New Seasonal Influenza Vaccine for Paediatric Use |
10/19/2009 |
FDA Approves Telmisartan, Amlodipine Combination Tablets for Hypertension |
10/19/2009 |
FDA Approves Telmisartan to Reduce Risk of Cardiovascular Events in High-Risk Patients |
10/19/2009 |
FDA Approves Rasburicase for Management of Hyperuricemia in Patients With Haematologic Malignancies |
10/19/2009 |
FDA Approves HPV Recombinant Vaccine, Types 16 and 18 |
10/16/2009 |
FDA Approves HPV Vaccine for Prevention of Genital Warts in Boys, Young Men |
10/12/2009 |
Zanamivir Dry Powder Should Not Be Delivered by Nebuliser, FDA Warns |
10/12/2009 |
FDA Approves a C1-Esterase Inhibitor for Abdominal Attacks, Facial Swelling Associated With HAE |
10/09/2009 |
FDA Conducting Safety Investigation of CT Brain Perfusion Scans |
10/07/2009 |
FDA Approves Colesevelam HCl for Children With Familial Hypercholesterolemia |
10/01/2009 |
FDA Approves Levonorgestrel IUD to Treat Heavy Menstrual Bleeding |
10/01/2009 |
Health Canada Approves Telavancin for Complicated Skin, Skin Structure Infections |
10/01/2009 |
New USP Standards for Heparin Products Will Result in Decreased Potency |
09/25/2009 |
FDA Conducting a Safety Review of Deferasirox Due to Reported Adverse Events |
09/25/2009 |
FDA Approves Ustekinumab for Moderate to Severe Psoriasis |
09/25/2009 |
FDA Recommends Labelling Change for Sitagliptin to Include Risk of Pancreatitis |
09/25/2009 |
FDA Approves Pralatrexate Injection for Relapsed, Refractory Peripheral T-Cell Lymphoma |
09/25/2009 |
FDA Warns of Potential Dosing Errors With Oseltamivir |
09/22/2009 |
FDA Continues to Receive Reports of PML in Patients Receiving Natalizumab |
09/17/2009 |
FDA Approves Single Pill Combination of Valsartan, Aliskiren for Hypertension |
09/16/2009 |
FDA Requires Boxed Warning for Promethazine Hydrochloride Injection |
09/16/2009 |
FDA Approves Ganciclovir Ophthalmic Gel for Herpetic Keratitis |
09/15/2009 |
FDA Approves Four Vaccines for the 2009 Influenza A(H1N1) Virus |
09/14/2009 |
Once-Daily Lopinavir/Ritonavir Tablet Approved in EU for Treatment-Naïve HIV Patients |
09/14/2009 |
FDA Approves Telavancin for Complicated Skin and Skin Structure Infections |
09/09/2009 |
FDA Approves Bepotastine Besilate Solution for Ocular Itching Associated With Allergies |
09/08/2009 |
FDA Approves Metoclopramide Rapid Dissolving Tablets for Diabetic Gastroparesis, GERD |
09/04/2009 |
FDA Approves Ibritumomab Tiuxetanton as First-Line Therapy for Non-Hodgkin's Lymphoma |
09/03/2009 |
Rituximab Approved in Europe for Patients With Previously-Treated CLL |
09/03/2009 |
FDA Approves Once-Daily Guanfacine XR for ADHD in Children, Adolescents |
08/31/2009 |
FDA Approves Valganciclovir Hydrochloride to Prevent CMV in Paediatric Transplant Recipients |
08/28/2009 |
FDA Approves Pancrelipase for Children, Adults With Exocrine Pancreatic Insufficiency |
08/25/2009 |
FDA Approves Levocetirizine Dihydrochloride for Paediatric Nasal Allergies |
08/24/2009 |
FDA Investigates Reports of Liver Damage From Weight Loss Drugs |
08/21/2009 |
FDA Approves Vigabatrin for Infantile Spasms |
08/17/2009 |
Rituximab Plus Chemotherapy Approved in Canada for Previously Untreated CLL |
08/17/2009 |
FDA Approves Treatment Protocol for Use of Glucocerebrosidase |
08/14/2009 |
FDA Reports Cases of Pure Red Cell Aplasia in Patients Treated With Mycophenolate Mofetil |
08/14/2009 |
Psychotropic Drug Asenapine Receives Simultaneous Initial FDA Approval for Schizophrenia and Bipolar I Disorder |
08/13/2009 |
FDA Approves Tamper-Proof Long-Acting Opioid for Management of Moderate to Severe Chronic Pain |
08/06/2009 |
EU Approves Everolimus for Second-Line Treatment of Advanced Kidney Cancer |
08/05/2009 |
Plerixa Injection Approved in EU to Enhance Mobilisation of Stem Cells |
08/03/2009 |
FDA Approves Pitavastatin for Primary Hypercholesterolaemia, Combined Dyslipidaemia |
08/03/2009 |
FDA Approves Bevacizumab Plus Interferon Alfa for Metastatic Renal Cell Carcinoma |
07/31/2009 |
Extended-Release Injectable Paliperidone Approved in the US for Schizophrenia |
07/31/2009 |
FDA Approves First Antipsychotic for Schizoaffective Disorder |
07/31/2009 |
FDA Approves Saxagliptin for Type 2 Diabetes |
07/30/2009 |
FDA Approves Treprostinil Inhalation Solution for Pulmonary Arterial Hypertension |
07/29/2009 |
EU Approves Bevacizumab Plus Docetaxel for First-Line Metastatic Breast Cancer Treatment |
07/23/2009 |
FDA Approves Expanded Use of Teriparatide (rDNA Origin) Injection to Treat Glucocorticoid-Induced Osteoporosis |
07/23/2009 |
FDA Approves Preservative-Free Ketorolac Formulation Ophthalmic Solution for Treatment of Pain, Inflammation Following Cataract Surgery |
07/23/2009 |
Increased Risk of Myocardial Infarction With Fosamprenavir |
07/21/2009 |
FDA Approves Aliskiren and Hydrochlorothiazide Combination Tablet for Patients Unlikely to Achieve Blood Pressure Goals With Single Agent |
07/20/2009 |
FDA Approves Vaccine for 2009-2010 Seasonal Influenza |
07/16/2009 |
FDA: Ongoing Omalizumab Study Shows Increased Number of Cardiovascular Events |
07/16/2009 |
FDA Approves Fentanyl Buccal Soluble Film for Breakthrough Pain |
07/14/2009 |
FDA Requires Labeling Changes for Immunosuppressant Drugs |
07/10/2009 |
FDA Approves Prasugrel to Reduce the Risk of MI During, After Angioplasty |
07/09/2009 |
Mometasone Furoate Dry Powder Inhaler Approved in Japan for Bronchial Asthma |
07/09/2009 |
Mirtazapine Approved in Japan for Major Depressive Disorder |
07/07/2009 |
FDA Takes Actions on Pain Medications Containing Propoxyphene |
07/07/2009 |
Tacrolimus Approved for Refractory Ulcerative Colitis in Japan |
07/06/2009 |
FDA Approves Pemetrexed as Maintenance Therapy for Advanced Lung Cancer |
07/02/2009 |
FDA Panel Recommends Withdrawal of Acetaminophen-Containing Narcotics |
07/02/2009 |
FDA Approves Dronedarone for Atrial Fibrillation or Atrial Flutter |
07/01/2009 |
FDA: Boxed Warning Required for Varenicline, Buproprion Due to Risk of Suicidal Behaviour |
07/01/2009 |
Gefitinib Approved in EU for Locally Advanced, Metastatic NSCLC |
06/30/2009 |
FDA Approves Ferumoxytol for Iron Deficiency Anaemia in Patients With CKD |
06/29/2009 |
Protein-Bound Paclitaxel Suspension Approved in Quebec for Metastatic Breast Cancer |
06/26/2009 |
Once-Yearly Zoledronic Acid Approved in EU for Glucocorticoid-Induced Osteoporosis |
06/25/2009 |
EMEA Recommends Withdrawal of Dextropropoxyphene-Containing Medicines |
06/22/2009 |
FDA Approves Diclofenac Potassium Oral Solution for Migraine |
06/18/2009 |
FDA Approves Canakinumab for Cryopyrin-Associated Periodic Syndrome |
06/18/2009 |
FDA Approves Dexamethasone Intravitreal Implant for Macular Oedema |
06/16/2009 |
Loss of Sense of Smell With Intranasal Cold Remedies Containing Zinc |
06/15/2009 |
Oseltamivir, Zanamivir for Influenza A(H1N1) Appear Safe for Pregnant Women |
06/15/2009 |
FDA Unable to Conclude Risk/Benefit Profile of Stimulant Drugs in Children With ADHD |
06/14/2009 |
FDA Issues Public Health Advisory Regarding Insulin Detemir |
06/12/2009 |
FDA Requests Labelling Change for Asthma Medications |
06/12/2009 |
Sevelamer Carbonate Approved in EU for Patients With Chronic Kidney Disease |
06/11/2009 |
FDA: Increased Mortality in Stable Liver Transplant Recipients Taking Sirolimus |
06/04/2009 |
Use of Mycophenolate Mofetil Associated With Pure Red Cell Aplasia, Warns Health Canada |
06/03/2009 |
FDA: Propylthiouracil Increases Risk of Serious Liver Injury, Death |
06/01/2009 |
FDA Warnings About Antidepressants Associated With Changes in Diagnosis, Treatment |
06/01/2009 |
FDA Approves Once-Daily Extended Release Lamotrigine for Epilepsy |
06/01/2009 |
FDA Approves Bi-Yearly Zoledronic Acid Injection to Prevent Osteoporosis in Postmenopausal Women |
05/31/2009 |
Lapatinib Ditosylate Plus Capecitabine Approved for Patients With HER2+ Breast Cancer in Canada |
05/29/2009 |
FDA Approves Besifloxacin to Treat Bacterial Conjunctivitis |
05/28/2009 |
FDA Approves Tacrolimus Plus Mycophenolate Mofetil for Prevention of Kidney Rejection in Transplant Recipients |
05/26/2009 |
FDA Approves Dasatinib for CML in Patients Resistant, Intolerant to Prior Therapies |
05/26/2009 |
FDA Approves Tadalafil Tablets for Pulmonary Arterial Hypertension |
05/22/2009 |
FDA Approves Tolvaptan for Patients With Clinically Significant Hypervolemic, Euvolemic Hyponatremia |
05/21/2009 |
Capsaicin Patch Approved for Peripheral Neuropathic Pain in Non-Diabetic Adults |
05/20/2009 |
Sorafenib Approved in Japan for the Treatment of Advanced Liver Cancer |
05/18/2009 |
FDA Approves Risperidone as Maintenance Treatment for Bipolar I Disorder |
05/14/2009 |
Certolizumab Approved in the United States for Moderate to Severe Rheumatoid Arthritis |
05/13/2009 |
FDA Approves Amlodipine, Olmesartan Medoxomil Combination Pill for Hypertension |
05/11/2009 |
EMEA Recommends Extension of Shelf-Life for Oseltamivir Capsules |
05/08/2009 |
FDA Warns of New Serious Adverse Events With Erlotinib |
05/07/2009 |
Testosterone Gel Safety Concerns Prompt FDA to Require Label Changes |
05/07/2009 |
Imatinib Approved in EU to Reduce Relapse Risk After GIST Surgery |
05/07/2009 |
FDA Approves Iloperidone for Schizophrenia |
05/06/2009 |
FDA Grants Accelerated Approval of Bevacizumab for Glioblastoma |
05/05/2009 |
Esomeprazole Approved in EU for Prevention of Peptic Ulcer Re-bleeding Following Endoscopy |
05/01/2009 |
FDA Approves Pancrelipase for Exocrine Pancreatic Insufficiency |
04/30/2009 |
FDA Approves Triple Combination Pill for Hypertension |
04/28/2009 |
Eslicarbazepine Approved in Europe for Partial-Onset Seizures |
04/27/2009 |
Long Acting Risperidone Injection Approved in Japan for Schizophrenia |
04/27/2009 |
Bazedoxifene Approved in EU for Postmenopausal Osteoporosis |
04/24/2009 |
Combination Telmisartan/Hydrochlorothiazide Pill Approved for Treating Hypertension in Japan |
04/24/2009 |
FDA Approves Golimumab for Treating 3 Types of Immune-Related Arthritis |
04/23/2009 |
NICE Appraises Lenalidomide Plus Dexamethasone for Multiple Myeloma |
04/23/2009 |
Etanercept Gets Revised Boxed Warning for Risk of Invasive Fungal Infections |
04/23/2009 |
Hepatitis B Injection Approved for Treating Acute Exposure |
04/21/2009 |
Health Canada Approves Methyl Aminolevulinate Cream for Use With Red Light Technology |
04/17/2009 |
Health Canada Approves Glatiramer Acetate for Clinically Isolated Syndrome Suggestive of MS |
04/13/2009 |
Golimumab Approved for Psoriatic Arthritis, Ankylosing Spondylitis, and RA in Canada |
04/08/2009 |
Manufacturer of Efalizumab Announces Voluntary Withdrawal From US Market |
04/02/2009 |
European Commission Approves Vaccine to Prevent Japanese Encephalitis |
04/01/2009 |
Bevacizumab Recommended for Accelerated Approval for Glioblastoma by FDA |
03/31/2009 |
Health Canada Approves Azithromycin Solution for Bacterial Conjunctivitis |
03/31/2009 |
European Commission Approves 10-Valent Paediatric Pneumococcal Vaccine |
03/31/2009 |
EMEA Removes Restriction of Bevacizumab Use in Patients With Brain Metastases |
03/30/2009 |
FDA Approves Vaccine to Prevent Japanese Encephalitis |
03/30/2009 |
FDA Approves Everolimus for Renal Cell Cancer When Sunitinib or Sorafenib Fail |
03/26/2009 |
Pandemic Influenza Vaccine for Humans Approved in Australia |
03/25/2009 |
NICE Recommends Sunitinib for First-Line Treatment of Renal Cell Carcinoma |
03/24/2009 |
Pioglitazone Hydrochloride Approved in Japan for Use With Insulin in Type 2 Diabetes |
03/24/2009 |
FDA Approves Tigecycline for Community-Acquired Bacterial Pneumonia |
03/24/2009 |
FDA Approves Olanzapine, Fluoxetine HCl for Treatment-Resistant Depression |
03/20/2009 |
FDA Approves Escitalopram Oxalate for Major Depressive Disorder in Adolescents |
03/17/2009 |
Health Canada Approves Hylan GF-20 for Osteoarthritis of the Knee |
03/05/2009 |
FDA, European Commission Approve IV Formulation of Temozolomide |
03/04/2009 |
FDA Approves Glatiramer Acetate for Symptoms Suggestive of MS |
02/27/2009 |
Rituximab Approved in EU for Chronic Lymphocytic Leukaemia |
02/26/2009 |
FDA Approves Intra-Articular Injection for Osteoarthritis of the Knee |
02/24/2009 |
Agomelatine Approved in EU for Major Depressive Episodes |
02/23/2009 |
Prasugrel Approved in EU for Patients With Acute Coronary Syndrome Undergoing PCI |
02/19/2009 |
EMEA Recommends Suspension of Efalizumab, FDA Continues Its Safety Review |
02/11/2009 |
Bevacizumab/Paclitaxel Combination Approved in Canada for First-Line Treatment of HER2-Negative Breast Cancer |
02/09/2009 |
Romiplostim Approved in the EU for Chronic Immune Thrombocytopenic Purpura |
02/06/2009 |
FDA Approves Antithrombin for Prevention of Thromboembolic Events |
02/04/2009 |
Glatiramer Acetate Approved for Patients With Clinical Isolated Syndrome Suggestive of MS |
02/04/2009 |
Once-Daily Darunavir Approved in EU for Treatment-Naïve Adults |
02/03/2009 |
FDA Approves Calcitriol for Mild-to-Moderate Plaque Psoriasis |
02/03/2009 |
Galsulfase Approved in Brazil for the Treatment of Mucopolysaccharidosis VI |
01/30/2009 |
Miglustat Approved in the EU for Niemann-Pick Type C Disease |
01/29/2009 |
Eculizumab Approved in Canada for Paroxysmal Nocturnal Haemoglobinuria (PNH) |
01/27/2009 |
FDA Approves Oxybutynin Chloride Gel for the Treatment of Overactive Bladder |
01/23/2009 |
EMEA Recommends New Contraindication for Toremifene |
01/22/2009 |
Ustekinumab Approved in EU for Moderate to Severe Plaque Psoriasis |
01/22/2009 |
Health Canada Approves Ziprasidone Hydrochloride for Bipolar Disorder |
01/21/2009 |
Tocilizumab Approved in EU for Rheumatoid Arthritis |
01/20/2009 |
Grass Pollens Desensitisation Tablets Approved in Germany for Paediatric Use |
01/16/2009 |
FDA Approves Fibrinogen Concentrate for Congenital Fibrinogen Deficiency |
01/15/2009 |
FDA Approves Milnacipran HCl for Fibromyalgia |
01/13/2009 |
Serious Adverse Effects Reported With Use of Botulinum Toxin Type A |
01/12/2009 |
Etanercept Approved in EU for Treatment of Paediatric Psoriasis |
01/12/2009 |
Three Lots of Dobutamine Hydrochloride Recalled Due to Dose Labelling Error |
01/07/2009 |
Health Canada: Important Changes to the Dose Conversion Guidelines for Fentanyl Transdermal Systems |
01/06/2009 |
FDA Approves Once-Daily Adapalene/Benzoyl Peroxide Gel for Acne Treatment |
01/05/2009 |
FDA Approves Amiodarone HCl for Recurring Ventricular Fibrillation, Ventricular Tachycardia |
12/31/2008 |
FDA Approves First Nucleic Acid Test to Screen for Additional Types of HIV in Donated Blood, Tissue |
12/31/2008 |
Efalizumab Associated With Serious Infections, Progressive Multifocal Leukoencephalopathy |
12/29/2008 |
FDA Approves Degarelix for Advanced Prostate Cancer |
12/24/2008 |
Azacitidine Approved in EU for Myelodysplastic Syndromes, AML |
12/22/2008 |
FDA Approves Gadofosveset Trisodium for Use With MRA to Evaluate Aortoiliac Occlusive Disease |
12/22/2008 |
Pioglitazone Hydrochloride Approved as Concomitant Therapy With Biguanides for Type 2 Diabetes in Japan |
12/22/2008 |
FDA Approves Imatinib Mesylate to Prevent Recurrence of GI Stromal Tumour |
12/19/2008 |
Wide Range of Eye Conditions Reported Following Off-label Use of Bevacizumab |
12/19/2008 |
FDA Approves Oral Formation of Fludarabine for Chronic Lymphocytic Leukaemia |
12/17/2008 |
Erlotinib Linked to Deaths in Patients With Hepatic Impairment, Advanced Solid Tumours |
12/17/2008 |
FDA Approves Plerixafor for Stem Cell Mobilisation in Non-Hodgkin's Lymphoma, Multiple Myeloma Patients |
12/16/2008 |
FDA: Antiepileptics Linked to Increased Risk of Suicidal Thoughts, Behaviour |
12/15/2008 |
FDA Approves Fenofibric Acid in Combination With Statins for Cholesterol Management |
12/15/2008 |
Ustekinumab Approved in Canada for Moderate to Severe Plaque Psoriasis |
12/15/2008 |
Lower-Dose Dasatinib Approved for Patients With Chronic Phase CML |
12/15/2008 |
FDA Approves Fospropofol Disodium for Monitored Anaesthesia Care Sedation |
12/12/2008 |
FDA Approves PEG-IFN Alfa-2b/Ribavirin Combination Therapy for Paediatric HCV |
12/11/2008 |
FDA: Boxed Warning of Oral Sodium Phosphate Products to Include Risk of Acute Phosphate Nephropathy |
12/09/2008 |
Sapropterin Dihydrochloride Approved in EU for Hyperphenylalaninaemia Due to Phenylketonuria, BH4 Deficiency |
12/04/2008 |
European Commission Approves New Indication for Peginterferon Alfa-2a |
12/03/2008 |
European Union Approves Darunavir for Treatment-Experienced Patients |
12/03/2008 |
European Union Approves Brinzolamide/Timolol Suspension for the Treatment of Glaucoma, Ocular Hypertension |
12/02/2008 |
FDA: Increased Risk of Mortality Associated With Tinzaparin Not Limited to Patients Over 90 Years |
12/01/2008 |
FDA Approves Synthetic Conjugated Oestrogens-A Vaginal Cream for Vulvar, Vaginal Atrophy Symptoms |
12/01/2008 |
Cetuximab Approved for First-Line Treatment of Head and Neck Cancer in Europe |
11/26/2008 |
FDA Grants Full Approval of Maraviroc for Treatment-Experienced Patients With HIV |
11/24/2008 |
Phenytoin, Fosphenytoin May Increase Risk of Serious Skin Reactions in Asian Patients With HLA-B*1502 Allele |
11/21/2008 |
FDA Approves Tapentadol for Relief of Moderate to Severe Acute Pain |
11/21/2008 |
Infection-Related Deaths Reported With Alemtuzumab, Warns Health Canada |
11/21/2008 |
FDA Approves Eltrombopag for the Treatment of Chronic Immune Thrombocytopenic Purpura |
11/18/2008 |
FDA Approves Rufinamide as Adjunctive Treatment for Lennox-Gastaut Syndrome |
11/18/2008 |
Methylnaltrexone Bromide Approved in Australia for the Treatment of Opioid-Induced Constipation |
11/13/2008 |
FDA Approves Oestrogen Vaginal Cream for Moderate to Severe Postmenopausal Dyspareunia |
11/13/2008 |
Swissmedic Approves Ceftobiprole Medocaril for Treatment of Complicated Skin Structure Infections |
11/06/2008 |
FDA Approves Ranolazine as First-Line Treatment of Chronic Angina |
11/03/2008 |
FDA Approves Bendamustine Hydrochloride for Patients With Relapsed Indolent Non-Hodgkin's Lymphoma |
10/31/2008 |
FDA Approves Fesoterodine Fumarate to Treat Overactive Bladder |
10/30/2008 |
Health Canada Warns of Venlafaxine Overdosage, Increased Risk of Fatal Outcome |
10/29/2008 |
FDA Approves Rapid-Acting Insulin Glulisine for Children With Diabetes |
10/29/2008 |
FDA Approves Lacosamide for Uncontrolled Partial-Onset Seizures |
10/29/2008 |
Single-Pill Combination Receives Swiss Approval for Treatment of Hypertension |
10/29/2008 |
Health Canada Approves Cetuximab for Advanced Colorectal Cancer, Head and Neck Cancer |
10/23/2008 |
European Medicines Agency Recommends Suspension of Rimonabant |
10/22/2008 |
Darunavir Receives Expanded Indication From FDA for Treatment-Naïve Adults |
10/21/2008 |
Alitretinoin Approved in France for Adults With Chronic Hand Eczema |
10/17/2008 |
Ethex Recalls 3 Lots of Dextroamphetamine Sulfate Due to Oversized Tablets |
10/16/2008 |
Pirfenidone Approved in Japan for Treatment of Idiopathic Pulmonary Fibrosis |
10/16/2008 |
FDA Approves Labeling Changes, Boxed Warning for Efalizumab |
10/16/2008 |
FDA Approves Denileukin Diftitox for Patients With Recurrent Cutaneous T-Cell Lymphoma |
10/16/2008 |
Nanoparticle Albumin-Bound Paclitaxel Approved in Australia for Metastatic Breast Cancer |
10/14/2008 |
Warning Label for Acetaminophen With Codeine to Include Nursing Mothers With Ultra-Rapid Metabolisers |
10/14/2008 |
Health Canada Approves Liquid Immune Globulin IV for Chronic Inflammatory Demyelinating Polyneuropathy |
10/10/2008 |
FDA Approves Drug to Prevent Joint Damage in Children with Haemophilia A |
10/10/2008 |
FDA Approves C1 Inhibitor Protein for the Prevention of Hereditary Angioedema Attacks |
10/10/2008 |
FDA Approves Quetiapine Fumarate for the Treatment of Bipolar Depression, Mania |
10/09/2008 |
Histamine Dihydrochloride Approved in Europe for Prevention of Relapse in Patients With AML |
10/09/2008 |
FDA Approves Silodosin for the Treatment of Benign Prostatic Hyperplasia |
10/06/2008 |
Health Canada Approves Lenalidomide for Treatment of Multiple Myeloma |
10/02/2008 |
FDA Approves Atazanavir Boosted With Ritonavir for Treatment-Naïve HIV Patients |
10/01/2008 |
Rivaroxaban Approved in EU for the Prevention of Venous Thromboembolic Events |
09/30/2008 |
Once-yearly Zoledronic Acid Approved in EU to Treat Osteoporosis in Men |
09/23/2008 |
FDA Approves Triamcinolone Acetonide for Allergic Rhinitis in Children Aged 2 to 5 years |
09/22/2008 |
Alitretinoin Approved in Denmark for Adults With Chronic Hand Eczema |
09/16/2008 |
Rivaroxaban Approved in Canada for the Prevention of Venous Thromboembolic Events |
09/15/2008 |
FDA Approves Expanded Uses for HPV Vaccine to Include Prevention of Certain Vulvar, Vaginal Cancers |
09/15/2008 |
FDA Approves Granisetron Patch for Chemotherapy-Induced Nausea, Vomiting |
09/15/2008 |
FDA Approves Once-Daily Levetiracetam as Adjunctive Therapy for Partial Onset Seizures |
09/12/2008 |
FDA Approves Treatment for Chronic Inflammatory Demyelinating Polyneuropathy |
09/11/2008 |
FDA: Fatal Case of Progressive Multifocal Leukoencephalopathy in Patient Receiving Rituximab |
09/10/2008 |
Bortezomib Combination Therapy Approved in Europe for Previously Untreated Multiple Myeloma |
09/08/2008 |
Bortezomib Approved in Canada as First-Line Treatment of Multiple Myeloma |
09/04/2008 |
FDA: TNF Blockers Increase Risk of Invasive Fungal Infections, Delayed Treatment Can Result in Death |
09/03/2008 |
Lacosamide Approved in Europe for Partial-Onset Epilepsy |
09/02/2008 |
Health Canada Approves Ceftobiprole Medocaril for Treatment of Complicated Skin Structure Infections |
08/29/2008 |
Etravirine Approved in the European Union for HIV Combination Therapy |
08/27/2008 |
NICE Final Guidance on Ranibizumab, Pegaptanib for Age-Related Macular Degeneration |
08/26/2008 |
Vaccine for the Prevention of Shingles Approved in Canada |
08/26/2008 |
Alutard SQ Approved for Asthma Prevention in Germany |
08/25/2008 |
FDA to Amend Natalizumab Label Based on New Cases of PML in Europe |
08/25/2008 |
Tramadol Receives Expanded Indication in Canada for Moderately Severe Pain |
08/22/2008 |
FDA Approves Romiplostim to Treat Chronic Immune Thrombocytopenic Purpura |
08/21/2008 |
FDA Investigating Possible Link Between Ezetimibe/Simvastatin and Increased Cancer Risk |
08/21/2008 |
Teriparatide Approved in Canada for Steroid-Induced Osteoporosis |
08/20/2008 |
Calcipotriene, Betamethasone Dipropionate Gel Approved in Europe for Scalp Psoriasis |
08/18/2008 |
FDA Receives More Reports of Acute Pancreatitis in Patients Taking Exenatide |
08/15/2008 |
FDA Approves Tetrabenazine for Treatment of Chorea in Huntington's Disease |
08/12/2008 |
FDA Issues Warning for Naltrexone Injection Site Reactions |
08/12/2008 |
Tenofovir Approved for Treatment of Chronic Hepatitis B in Adults |
08/12/2008 |
Temsirolimus Associated With Hypersensitivity/Infusion Reactions, Warns Health Canada |
08/08/2008 |
FDA: Watch for Rhabdomyolysis When Simvastatin, Amiodarone Are Coadministered |
08/06/2008 |
Single Lot of Epoetin Alfa Recalled Due to Damaged Vials |
08/06/2008 |
EU Extends Indication of Bosentan to Pulmonary Arterial Hypertension WHO FC II |
08/06/2008 |
FDA Approves Expanded Use of Caspofungin Acetate for Paediatric Patients |
08/05/2008 |
FDA Approves 6 Flu Vaccines for 2008-2009 Influenza Season |
08/05/2008 |
FDA Approves Injectable Clevidipine Butyrate for Treatment of Hypertension |
08/04/2008 |
Naltrexone Approved in Russia for Treatment of Alcohol Dependence |
08/04/2008 |
FDA Approves Single Combination Pills for First-Line Treatment of Hypertension |
07/31/2008 |
FDA Clarifies Approved Conditions for Use of ESAs |
07/30/2008 |
FDA Approves Valproate for Bipolar Disorder, Seizures, and Migraine Headaches |
07/29/2008 |
FDA: Watch Cardiac Function in MS Patients During and After Mitoxantrone Therapy |
07/24/2008 |
EMEA Recommends Strengthened Warnings, Restricted Use of Oral Moxifloxacin |
07/24/2008 |
Contaminated Nelfinavir Does Not Increase Cancer Risk, EMEA Concludes |
07/24/2008 |
EMEA Restricts Use of Oral Norfloxacin Drugs in UTIs |
07/24/2008 |
FDA Recommends Genetic Screening Prior to Treatment With Abacavir |
07/23/2008 |
Cetuximab as First-Line Treatment in Metastatic Colorectal Cancer Approved in Europe |
07/22/2008 |
Sitagliptin/Metformin HCl Approved in Europe for Type 2 Diabetes |
07/18/2008 |
Sandoz Timolol Ophthalmic Solution Recalled Due to Potential Health Risk |
07/18/2008 |
Intranasal Desmopressin Loses Indication for Primary Nocturnal Enuresis in Canada |
07/16/2008 |
Cetuximab Approved in Japan for Treatment of Metastatic Colorectal Cancer |
07/16/2008 |
Argatroban Hydrate Receives Expanded Approval for Thrombosis in Japan |
07/15/2008 |
European Commission Approves Icatibant for the Treatment of Hereditary Angio-Oedema |
07/14/2008 |
Bevacizumab Plus Sunitinib Linked to Rare Anaemia in Patients With Solid Tumours, Warns FDA |
07/14/2008 |
European Commission Approves Nicotinic Acid/Laropiprant for Treatment of Hypercholesterolaemia |
07/14/2008 |
Albumin-Bound Paclitaxel Approved for Metastatic Breast Cancer in China |
07/11/2008 |
Bevacizumab Plus Sunitinib Linked to Rare Anaemia in Metastatic Renal Cancer, Warns Health Canada |
07/10/2008 |
European Commission Approves Ranolazine for Treatment of Patients With Chronic Angina |
07/09/2008 |
Ratio-Morphine Tablets Recalled in Canada Due to Risk of Accidental Overdose |
07/08/2008 |
FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs |
07/08/2008 |
European Commission Approves Once-Weekly Etanercept for Psoriasis |
07/03/2008 |
European Commission Approves Methylnaltrexone Bromide for Opioid-Induced Constipation in Advanced Illness |
07/01/2008 |
FDA Approves Rabeprazole for Short-Term Treatment of GERD in Adolescents |
06/30/2008 |
Ceftobiprole Approved in Canada for Treatment of Complicated Skin Infections |
06/27/2008 |
EMEA Recommends New Warning Label for Epoetin-Containing Medication |
06/27/2008 |
EMEA Recommends Updated Label Warnings for Etoricoxib-Containing Drugs |
06/27/2008 |
FDA Approves Methylphenidate HCl Extended-Release Tablets for Treatment of ADHD in Adults |
06/26/2008 |
Sublingual Fentanyl Approved in Europe for Breakthrough Cancer Pain |
06/26/2008 |
European Commission Approves Shortened Treatment With Peginterferon Alfa-2a Plus Ribavirin for Specific Hepatitis C Patients |
06/25/2008 |
Potential Risk of Cardiac Events in Patients Treated With Abacavir-Containing Products |
06/25/2008 |
Oralair Grasses Approved for Adults With Allergic Rhinoconjunctivitis in Germany |
06/25/2008 |
FDA Approves New Combination Vaccine for Children |
06/24/2008 |
FDA Approves New Tipranavir Oral Solution for Treatment-Experienced Paediatric, Adolescent HIV Patients |
06/24/2008 |
FDA Approves Topical Steroid for Treatment of Postoperative Ocular Inflammation, Pain |
06/24/2008 |
FDA Gives Nod to New Diabetes Combination Tablet: Repaglinide + Metformin |
06/23/2008 |
FDA Approves Pentacel, a Paediatric Combination Vaccine |
06/23/2008 |
FDA Approves Bortezomib for Patients With Previously Untreated Multiple Myeloma |
06/23/2008 |
FDA Approves Dutasteride in Combination With Tamsulosin for the Treatment of Symptomatic Enlarged Prostate |
06/18/2008 |
FDA Approves Diaphragm-Pacing Device |
06/18/2008 |
FDA Requests Boxed Warnings on Conventional Antipsychotic Drugs |
06/17/2008 |
TGA Approves Panvax, Avian Flu Vaccine |
06/17/2008 |
FDA Approves Triamcinolone Acetone Formulation for Ocular Use |
06/16/2008 |
Oral Anticoagulant Dabigatran Etexilate Approved in Canada |
06/16/2008 |
FDA Approves Duloxetine HCl for the Management of Fibromyalgia |
06/13/2008 |
Lapatinib Approved in Europe for Breast Cancer |
06/10/2008 |
Single Lot of Morphine Sulfate 60-mg Extended Release Tablets Recalled |
06/07/2008 |
Health Canada Approves New Treatment for Bipolar Mania |
06/07/2008 |
US FDA Announces New Labelling Changes for Becaplermin |
06/05/2008 |
US FDA Approves Zoledronic Acid for Prevention of Fractures Following a Hip Fracture |
05/30/2008 |
Alteplase Approved in European Union for Catheter Dysfunction Caused by Thrombotic Occlusion |
05/27/2008 |
Idursulfase Approved in Brazil for Treatment of Hunter Syndrome |
05/27/2008 |
FDA Approves Thrombin, Topical (Recombinant), 20,000-IU Vial Size for Haemostasis |
05/27/2008 |
Interferon Beta-1b (Extavia) Approved in European Union for Treatment of Multiple Sclerosis |
05/21/2008 |
FDA Approves Alvimopan to Help Restore Bowel Function Following Surgery |
05/20/2008 |
Pre-Pandemic Vaccine Approved in EU to Protect Against H5N1 Influenza |
05/20/2008 |
Reformulated Liquid Sargramostim Now Available in the US |
05/19/2008 |
Medicis Voluntarily Recalls Solodyn (Minocycline HCl) Extended Release Due to Product Mix-Up |
05/16/2008 |
CDC Recommends Vaccine for Shingles |
05/15/2008 |
Bayer Removes Remaining Stocks of Aprotinin; Access Limited to Investigational Use |
05/14/2008 |
FDA Approves Quetiapine for Maintenance Treatment in Bipolar Disorder |
05/13/2008 |
Topotecan Approved in Europe for Treatment of Relapsed Small-Cell Lung Cancer |
05/12/2008 |
FDA Approves New Formulation of Coagulation Therapy That Can Be Stored at Room Temperature |
05/09/2008 |
FDA Approves Generic Ropinirole Hydrochloride for Treatment of Restless Legs Syndrome |
05/09/2008 |
FDA Approves Aripiprazole as Adjunctive to Lithium or Valproate in Adults With Bipolar 1 Disorder |
05/09/2008 |
Aripiprazole Receives Expanded Paediatric Indications for Bipolar I Disorder and Schizophrenia |
05/09/2008 |
FDA Approves Atomoxetine for Maintenance of ADHD in Children and Adolescents |
05/07/2008 |
Micafungin Approved in Europe for Treatment and Prevention of Fungal Infections |
05/07/2008 |
Low-Dose, Drospirenone-Containing Oral Contraceptive Approved in Europe |
05/06/2008 |
Febuxostat Approved in Europe for the Treatment of Chronic Hyperuricaemia in Patients With Gout |
05/01/2008 |
FDA Approves Fluticasone/Salmeterol Inhalation Powder for Reduction of COPD Exacerbations |
04/30/2008 |
FDA Approves Lubiprostone as First Drug Treatment for IBS With Constipation |
04/29/2008 |
US Recalls Some Digoxin Tablets, May Contain Twice the Approved Level of Active Ingredient |
04/28/2008 |
Tipranavir Approved in Europe for Suppression Treatment of HIV |
04/28/2008 |
90Y-Ibritumomab Tiuxetan Approved in Europe for Treatment of Follicular Lymphoma |
04/25/2008 |
Tenofovir Disoproxil Fumarate Approved in Europe for Treatment of Chronic Hepatitis B |
04/25/2008 |
Methylnaltrexone Bromide Receives FDA Approval for Opioid-Induced Constipation |
04/24/2008 |
FDA Approves Once-Daily Lisdexamfetamine to Treat ADHD in Adults |
04/22/2008 |
Dutasteride Plus Tamsulosin Approved for Benign Prostatic Hyperplasia in Sweden |
04/22/2008 |
Sunitinib Approved in Japan for GIST and Renal Cell Carcinoma |
04/22/2008 |
FDA Approves Certolizumab to Treat Crohn's Disease |
04/21/2008 |
Europe Approves New Fixed-Dose Combination Drug for Essential Hypertension |
04/21/2008 |
Thalidomide Agent Approved in the European Union for the Treatment of Newly Diagnosed Multiple Myeloma |
04/17/2008 |
FDA Finds Generic Bupropion XL Safe and Effective |
04/17/2008 |
Tocilizumab Approved in Japan for the Treatment of Rheumatoid Arthritis |
04/17/2008 |
FDA Approves Combination Sumatriptan/Naproxen Sodium for Acute Treatment of Migraine |
04/16/2008 |
FDA Approves Olopatadine Nasal Spray for Treatment of Nasal Allergy Symptoms |
04/14/2008 |
Fixed-Dose Combination 80 mg Telmisartan/25 mg Hydrochlorothiazide Approved in Europe for the Treatment of Essential Hypertension |
04/14/2008 |
Fentanyl Approved in Europe for the Treatment of Breakthrough Cancer Pain |
04/11/2008 |
Pemetrexed Approved in Europe for Histologically-Based First-Line Treatment of Advanced Non-Small-Cell Lung Cancer |
04/10/2008 |
FDA Investigates Reports of PML in Patients Taking Mycophenolate Mofetil and Mycophenolic Acid |
04/08/2008 |
FDA Approves Abatacept for the Treatment of Polyarticular Juvenile Idiopathic Arthritis |
04/08/2008 |
Cancer Vaccine Approved in Russia for Patients With Intermediate-Risk Renal Cell Carcinoma |
04/08/2008 |
European Commission Approves Aripiprazole for Bipolar I Disorder |
04/07/2008 |
Lower-Strength Lopinavir/Ritonavir Tablet Approved in Europe for Paediatric Patients With HIV |
04/07/2008 |
Australian Agency Approves Thalidomide for the Treatment of Newly Diagnosed Multiple Myeloma |
04/04/2008 |
European Commission Approves Teriparatide for the Treatment of Glucocorticoid-Induced Osteoporosis |
04/04/2008 |
FDA Approves New Vaccine to Prevent Gastroenteritis Caused by Rotavirus |
04/03/2008 |
Covidien Initiates Voluntary Recall of Pre-Filled Syringes Containing Heparin |
03/27/2008 |
Dabigatran Approved in Europe for Thromboprophylaxis Following Hip or Knee Replacement Surgery |
03/27/2008 |
Becaplermin May Increase Risk of Death From Cancer in Patients With Diabetes |
03/27/2008 |
US FDA Issues Update of Ongoing HIV Drug Safety Review |
03/27/2008 |
Possible Link Between Montelukast and Suicidality, US FDA Investigates |
03/26/2008 |
Valsartan Approved in Canada for the Treatment of Patients With Chronic Heart Failure |
03/20/2008 |
FDA Approves Bendamustine Hydrochloride for Use in Chronic Lymphocytic Leukaemia |
03/20/2008 |
European Agency Warns of Potential Liver Injury With Natalizumab Treatment |
03/20/2008 |
UCB Advises US-Physicians to Down-Titrate Patients on Neupro in View of Out-Of-Stock Situation in the US |
03/20/2008 |
FDA Approves New Medical Adhesive to Treat Burn Patients |
03/18/2008 |
FDA Approves First Insulin Analog for Use in Insulin Pumps by Children, Adolescents |
03/17/2008 |
Etanercept PI Gets Boxed Warning for Risk of Infections, Tuberculosis |
03/11/2008 |
Misuse of Hydrocodone-Containing Cough Suppressant Linked to Life-Threatening Adverse Events |
03/04/2008 |
Oral Verapamil HCl Approved in Japan for Tachyarrhythmia |
03/03/2008 |
FDA Approves Palonosetron for Prevention of Postoperative Nausea and Vomiting |
03/03/2008 |
FDA Approves Desvenlafaxine for Treatment of Adults With Major Depressive Disorder |
03/03/2008 |
Actavis Recalls Remaining Fentanyl Patches in the US as Precaution |
03/03/2008 |
FDA Approves Three New Dosage Strengths of Oxymorphone HCl Extended Release |
02/29/2008 |
FDA Approves Aripiprazole for Paediatric Patients With Bipolar Disorder |
02/28/2008 |
Baxter to Recall Remaining Heparin Vial Products |
02/28/2008 |
FDA Approves Rilonacept for the Treatment of Rare Inflammatory Syndromes |
02/28/2008 |
FDA Approves Esomeprazole for Use in Children Ages 1-11 Years |
02/25/2008 |
Single-Tablet Galvus/Metformin Approved in EU for Patients With Type 2 Diabetes |
02/22/2008 |
FDA Approves Bevacizumab for Metastatic Breast Cancer |
02/22/2008 |
FDA Approves Adalimumab for the Treatment of Juvenile Idiopathic Arthritis |
02/21/2008 |
FDA Licenses New Hemophilia Treatment |
02/19/2008 |
FDA Approves Xyzal (Levocetirizine Dihydrochloride) Oral Solution for Allergic Rhinitis and Chronic Idiopathic Urticaria |
02/18/2008 |
Potential Defect Triggers Another Recall of Fentanyl Patches in the US |
02/12/2008 |
Fentanyl 25 mcg Patches Recalled |
02/11/2008 |
Baxter's Multiple-Dose Vial Heparin Linked to Severe Allergic Reactions |
02/08/2008 |
FDA: Botulinum Toxins Linked to Respiratory Failure and Death |
02/04/2008 |
FDA Approves Asmanex Twisthaler for Asthma Maintenance in Pediatric Patients |
02/01/2008 |
Galvus Approved in European Union for Treatment of Type 2 Diabetes |
01/31/2008 |
FDA Analysis Showed Patients Receiving Antiepileptic Drugs Had Approximately Twice The Risk of Suicidal Behavior Or Ideation |
01/29/2008 |
Champix Approved in Japan as Smoking Cessation Aid |
01/29/2008 |
Angiox Receives European Authorization for Expanded Use in Patients with Acute Coronary Syndromes |
01/29/2008 |
FDA Approves Emend Injections for Prevention of Nausea and Vomiting Caused by Chemotherapy |
01/28/2008 |
Clexane/Lovenox Approved in Japan for Thrombosis Prevention in Orthopaedic Surgery Patients |
01/28/2008 |
Avastin Receives Label Extension in Europe for Treatment of Patients With Metastatic Colorectal Cancer |
01/28/2008 |
Sorafenib (Nexavar) Approved in Japan for Treatment of Advanced Renal Cell Carcinoma |
01/25/2008 |
FDA to Conduct a Review of Vytorin's ENHANCE Trial Once the Final Study Results Are Available |
01/24/2008 |
EMEA Statement on the Safety of Gardasil |
01/24/2008 |
EMEA Recommends New Warnings and Contraindications for Rosiglitazone |
01/23/2008 |
Bayer Withdraws Liquid Formulation of Leukine (sargramostim) in US Due to Adverse Reactions |
01/21/2008 |
Tekturna HCT Receives US Approval For Treatment of High Blood Pressure |
01/21/2008 |
Humira (adalimumab) Receives FDA Approval for Moderate to Severe Chronic Plaque Psoriasis |
01/21/2008 |
FDA Issues Recall of Heparin |
01/21/2008 |
FDA Approves New HIV Drug After Priority Review |
01/18/2008 |
FDA Approves Update to Label on Birth Control Patch |
01/18/2008 |
FDA Releases Recommendations Regarding Use of Over-the-Counter Cough and Cold Products |
01/18/2008 |
Chantix (varenicline) Label Updated to Include Warning for Neuropsychiatric Symptoms |
01/18/2008 |
FDA Approves First Clotting Solution Made Using Recombinant DNA Technology |
01/16/2008 |
FDA Issues Public Health Advisory for Edetate Disodium |
01/16/2008 |
Allergic Rhinitis Treatment Avamys (fluticasone furoate) Approved in Europe |
01/14/2008 |
FDA Approves TYSABRI® (natalizumab) for the Treatment of Moderate-to-Severe Crohn's Disease |
01/09/2008 |
FDA Takes Action Against Compounded Menopause Hormone Therapy Drugs |
01/08/2008 |
FDA Approves Cialis (tadalafil) for Once Daily Use for the Treatment of Erectile Dysfunction |
01/07/2008 |
FDA Provides Updated Information on Bisphosphonates |
12/28/2007 |
Ultiva (Remifentanil hydrochloride) Recalled in Canada Due to Potential for Overdose |
12/28/2007 |
FDA Approves Product to Treat Serious Blood Volume Loss following Surgery |
12/21/2007 |
Health Canada Endorses Safety Information on Modafinil (Alertec) |
12/21/2007 |
Important Information for the Safe Use of Fentanyl Transdermal System (Patch) |
12/20/2007 |
CDC, AAFP, Others Release Interim Hib Vaccine Recommendations |
12/20/2007 |
Abbott's HUMIRA® Approved in the European Union for Treatment of Moderate-to-Severe Plaque Psoriasis |
12/19/2007 |
Avastin Approved in Europe for First-Line Treatment of Patients with Advanced Kidney Cancer |
12/17/2007 |
European Commission Approves Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) |
12/12/2007 |
Carbamazepine Prescribing Information to Include Recommendation of Genetic Test for Patients with Asian Ancestry |
12/04/2007 |
FDA Alert: Desmopressin Acetate Linked to Seizures, Death in Children With PNE |
12/03/2007 |
FDA Approves Diovan® for Treatment of High Blood Pressure in Children |
11/30/2007 |
FDA Approves Cymbalta® for Maintenance Treatment of Major Depressive Disorder |
11/29/2007 |
AstraZeneca Receives European Approval for Nexium in Paediatric GERD |
11/29/2007 |
Merck KGaA's Cyanokit Approved in the European Union |
11/28/2007 |
Tasigna® Gains European Approval for Patients With a Life-Threatening Form of Leukemia Who Are Resistant Or Intolerant to Existing Therapies |
11/28/2007 |
Health Canada Approves ERAXIS(TM) (anidulafungin), a New Antifungal Agent with Potent Effect Against Life-Threatening Fungal Infections |
11/27/2007 |
FDA Issues Safety Warning Over Myfortic (mycophenolic acid) Delayed-Release Tablets |
11/26/2007 |
Health Canada Issues an Update on Availability of Trasylol (aprotinin) |
11/26/2007 |
Wyeth's Torisel Receives European Commission Approval for the Treatment of Advanced Kidney Cancer |
11/20/2007 |
FDA Reviewing Post-Marketing Cases Describing Suicidal Ideation and Occasional Suicidal Behavior With Chantix (Varenicline) |
11/20/2007 |
Abilify(R) (Aripiprazole) Approved by U.S. FDA for Add-On Treatment of Major Depressive Disorder |
11/20/2007 |
FDA Approves Avalide® (irbesartan-hydrochlorothiazide) as First Combination Therapy for Initial Use in Patients Likely to Need Multiple Drugs to Achieve Blood Pressure Goals |
11/19/2007 |
FDA Notice of Potentially Harmful "Cosmetic" Eye Product |
11/19/2007 |
FDA Approves Nexavar for Treatment of Liver Cancer |
11/19/2007 |
Sale of Prexige (Lumiracoxib) Suspended in UK and Germany |
11/19/2007 |
Prexige (Lumiracoxib) License Suspended in UK |
11/16/2007 |
EMEA Recommends Changes in Product Information for Protelos/Osseor Due to Risk of Severe Hypersensitivity Reactions |
11/16/2007 |
FDA Approves Protonix(R) pantoprazole sodium) for Delayed-Release Oral Suspension for Erosive Gastroesophageal Reflux Disease |
11/16/2007 |
Seroquel XR(TM) (quetiapine fumarate) Receives Approval From FDA for Maintenance Treatment of Schizophrenia |
11/15/2007 |
New Crestor(R) (rosuvastatin calcium) Indication Approved in U.S. to Slow Progression of Atherosclerosis in Patients With High Cholesterol |
11/15/2007 |
Pegintron(TM) (peginterferon alfa-2b) and Rebetol(R) (ribavirin) Approved in European Union for Retreating Hepatitis C Patients Who Failed Previous Pegylated or Non-Pegylated Interferon Therapy |
11/15/2007 |
U.S. FDA Approves Lower-Strength Kaletra(R) (lopinavir/ritonavir) Tablet for Pediatric HIV Patients |
11/15/2007 |
FDA Approves Mircera (methoxy polyethylene glycol-epoetin beta) for Treatment of Renal Anemia in US With Monthly Maintenance Dosing |
11/15/2007 |
Cefepime (Maxipime) - Early Communication About An Ongoing Safety Review |
11/14/2007 |
Natrecor Authorized in Canada for Treatment of Acute Decompensated Heart Failure |
11/14/2007 |
FDA Adds Boxed Warning for Heart Attacks to Anti-Diabetes Drug Avandia |
11/13/2007 |
Nexavar Becomes First Approved Systemic Treatment of Hepatocellular Carcinoma in Europe |
11/09/2007 |
FDA Approves New Sprycel(R) (Dasatinib) Product Labeling for Patients With Chronic-Phase CML |
11/08/2007 |
FDA Strengthens Boxed Warnings, Approves Other Safety Labeling Changes for Erythropoiesis-Stimulating Agents |
11/06/2007 |
Aclasta(R) (Zoledronic Acid) receives Health Canada approval as first and only once-yearly treatment for women with postmenopausal osteoporosis |
11/06/2007 |
U.S. FDA Approves Abilify® (Aripiprazole) for Adolescent Patients With Schizophrenia |
11/05/2007 |
FDA Requests Marketing Suspension of Trasylol |
10/31/2007 |
FDA Approves CombiganTM (Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution) for Reduction of Intraocular Pressure |
10/30/2007 |
Tasigna® (Nilotinib) Receives U.S. Approval for Chronic Myeloid Leukemia in Patients With Resistance or Intolerance to Existing Therapies |
10/30/2007 |
Nexavar® (Sorafenib) Approved for Hepatocellular Carcinoma in Europe |
10/29/2007 |
FDA Medwatch: Use of CellCept (Mycophenolate Mofetil) Associated With Increased Pregnancy Loss and Congenital Malformations |
10/25/2007 |
Early Communication about an Ongoing Safety Review - Aprotinin Injection (marketed as Trasylol) |
10/24/2007 |
Provigil (modafinil) Tablets - Warnings Added to Prescribing Information Regarding Serious Rash and Hypersensitivity Reactions, and Psychiatric Symptoms |
10/24/2007 |
FDA Announces Revisions to Labels for Cialis, Levitra and Viagra |
10/22/2007 |
FDA Approves Change in Storage Conditions for Humate-P |
10/19/2007 |
Important Safety Information Released on Definity(R) (Perflutren Injectable Suspension) and Serious Cardiopulmonary Reactions |
10/19/2007 |
FDA Expands Age Range for Use of Bacterial Meningitis Vaccine |
10/18/2007 |
FDA Approves Ixabepilone for the Treatment of Advanced Breast Cancer |
10/18/2007 |
FDA Approves New HIV Drug, Raltegravir Tablets, Used in Combination With Other Antiretroviral Agents |
10/18/2007 |
FDA Approves New Drug to Treat Complicated Urinary Tract and Intra-Abdominal Infections |
10/18/2007 |
European Medicines Agency Recommends Withdrawal of Marketing Authorisations for Cough Medicines Containing Clobutinol |
10/17/2007 |
FDA Approves New Treatment for Diabetes |
10/16/2007 |
Byetta (Exenatide) and Postmarketing Reports of Acute Pancreatitis |
10/15/2007 |
Contraindicated Use of Sibutramine and Cardiovascular Adverse Reactions |
10/12/2007 |
Reports of Deaths and Serious Cardiopulmonary Reactions Following Administration of Ultrasound Micro-Bubble Contrast Agents Used in Echocardiography |
10/11/2007 |
Iressa® (gefitinib) 250 mg Tablets Fail to Demonstrate Non-inferiority in Overall Survival Versus Docetaxel |
10/11/2007 |
Pediatric Cough and Cold Remedies Recalled by Manufacturers |
10/08/2007 |
Intravascular Ultrasound Crucial in Assessing Atherosclerosis After Statin Therapy: Presented at DALM |
10/08/2007 |
With Ezetimibe, the novel MTP Inhibitor, AEGR-733, Lowers LDL-C in Statin-Intolerant Patients: Presented at DALM |
10/08/2007 |
Cholesterol-Lowering Ezetimibe/Simvastatin Is a Novel Way for Type 2 Diabetes Patients to Reduce CVD Risk: Presented at DALM |
10/08/2007 |
Anti-Depressant Drugs Can Double Risk of Gastrointestinal Bleeding |
10/08/2007 |
Tablet is better all round for cancer patients |
10/08/2007 |
Atorvastatin's Effect in Alzheimer's Dementia -- Preliminary Data from LEADe: Presented at DALM |
10/04/2007 |
Withdrawal of Market Authorization for Prexige (Lumiracoxib) |
10/02/2007 |
Early Communication Issued Regarding Atrial Fibrillation With Oral and Intravenous Bisphosphonates |
10/01/2007 |
Letter Issued Regarding Boxed Warning and Revisions to Warning Section of Prescribing Information for Gadolinium-Based Contrast Agent |
09/28/2007 |
Additional Influenza Vaccine Approved for Upcoming Influenza Season |
09/28/2007 |
FDA Takes Action to Stop Marketing of Unapproved Hydrocodone Products |
09/28/2007 |
Health Canada Recalls Sodium Phosphates Injection, USP Due to Out of Specification Result for Aluminum Content |
09/26/2007 |
FDA Warns of Potential Serious Side Effects with Breakthrough Cancer Pain Drug |
09/21/2007 |
Axcil and Desirin Dietary Supplements Recalled Because They Were Found to Contain Potentially Harmful Ingredients |
09/21/2007 |
European Medicines Agency Recommends Restricted Use of Nimesulide-containing Medicinal Products |
09/20/2007 |
FDA Proposing Phase Out of CFCs in Metered-Dose Inhalers for Epinephrine |
09/20/2007 |
European Medicines Agency recommends lifting of suspension for Viracept (Nelfinavir, as Nelfinavir Mesilate) |
09/18/2007 |
Haloperidol Marketed as Haldol, Haldol Decanoate, and Haldol Lactate Get New Warnings and Revised Prescription Information |
09/13/2007 |
Letter to Health Care Providers Sent Out With Safety Information Regarding Fentora (Fentanyl Buccal Tablet) |
09/11/2007 |
Letter to Physicians Sent to Clarify Potential Risk Associated With Concomitant Use of Rocephin (Ceftriaxone Sodium) With Calcium Containing Products |
09/10/2007 |
Viracept (Nelfinavir Mesylate) Guidance on Use in Pregnant Women and Pediatric Patients Due to Presence of Potential Human Carcinogen |
09/10/2007 |
Access Granted for New Treatment Option for Scots With Stomach Cancer |
09/07/2007 |
Zencore Tabs Dietary Supplement Recalled - Found to Contain Potentially Harmful Ingredients |
09/05/2007 |
Ketek (telithromycin) No Longer Approved in Canada for Treatment of Bronchitis, Sinusitis or Tonsillitis/Pharyngitis |
09/04/2007 |
FDA Approves Second-Generation Smallpox Vaccine |
08/31/2007 |
FDA Approves New Drug to Treat Rare Disease, Acromegaly |
08/29/2007 |
FDA Approves Human Thrombin for Topical Use in Surgery |
08/23/2007 |
Safety Information Regarding Thelin (Sitaxsentan Sodium) and the Occurrence of Liver Toxicity, Risks to the Foetus, and Important Drug-Drug Interactions |
08/22/2007 |
FDA Approves Risperdal for Two Psychiatric Conditions in Children and Adolescents |
08/17/2007 |
FDA Warning - Codeine Use by Nursing Mothers May Increase Chance of Serious Side Effects in Infants |
08/16/2007 |
Baraclude (Entecavir) Not Recommended for HIV/HBV Co-Infected Patients Who Are Not Also Receiving HAART Due to Potential for Development of HIV Resistance |
08/16/2007 |
FDA Approves Updated Warfarin (Coumadin) Prescribing Information |
08/16/2007 |
New Safety Information Regarding Prexige (Lumiracoxib) |
08/16/2007 |
Eli Lilly to Cease Sale of Permax Due to Risk of Cardiac Valvulopathy |
08/14/2007 |
Manufacturers of Some Diabetes Drugs to Strengthen Warning on Heart Failure Risk |
08/14/2007 |
Kaletra (Lopinavir/Ritonavir) Oral Solution - Healthcare Provider Letter Regarding Proper Dosing for Kaletra Oral Solution |
08/14/2007 |
FDA Grants Tentative Approval for 50th and 51st Anti-Retroviral Drugs Under President's AIDS Relief Plan |
08/10/2007 |
New Cause of Tamoxifen Resistance in Breast Cancer Cells Discovered at Lombardi |
08/09/2007 |
Prilosec (omeprazole), Nexium (esomeprazole) - Early Communication About Ongoing Safety Review |
08/07/2007 |
FDA Approves Maraviroc for Adults With HIV |
07/27/2007 |
FDA Permits Restricted Use of Zelnorm for Qualifying Patients |
07/23/2007 |
Health Canada Warns Consumers Not to Use Zencore Tabs Due to Potential Health Risks |
07/23/2007 |
European Medicines Agency recommends withdrawal of medicinal products containing veralipride |
07/19/2007 |
European Medicines Agency Recommends Acomplia Must Not Be Used in Patients on Antidepressants or With Major Depression |
07/06/2007 |
Rocephin (Ceftriaxone Sodium) - Contraindications, Warnings, Precautions, Adverse Reactions, Dosage and Administration Sections of Labeling Revised |
07/05/2007 |
Merck Recalls 3 Lots of Invanz (ertapenem sodium) Injection Because the Product May Contain Broken Glass Pieces in the Reconstituted Solution for Injection |
06/27/2007 |
Voluntary Recall of One Lot of Fluotic® (sodium fluoride) 20 mg tablets and Notice of Product Discontinuation |
06/27/2007 |
Sensipar® No Longer Indicated for Chronic Kidney Disease Patients (Stages 3 and 4) Not Receiving Dialysis |
06/21/2007 |
FDA Approves First Drug for Treating Fibromyalgia |
06/18/2007 |
FDA Approves New Orphan Drug for Treatment of Pulmonary Arterial Hypertension |
06/12/2007 |
Association of Avastin With Tracheoesophageal Fistula |
06/06/2007 |
Roche Recalls Viracept Due to Chemical Impurity |
05/31/2007 |
FDA Approves New Drug for Advanced Kidney Cancer |
05/28/2007 |
Novel Chloride Channel Activator Relieves Symptoms of Irritable Bowel Syndrome: Presented at DDW |
05/23/2007 |
FDA Requests Boxed Warning for Contrast Agents Used to Improve MRI Images |
05/22/2007 |
FDA Approves Contraceptive for Continuous Use |
05/22/2007 |
FDA notifies healthcare professionals of changes to Exjade labeling |
05/21/2007 |
FDA Issues Safety Alert on Avandia |
05/16/2007 |
FDA Approves Expanded Use for Surgical Sealant |
05/15/2007 |
Irish Board Suspends Marketing of Drugs Containing Nimesulide |
05/11/2007 |
FDA Approves Neupro Patch for Treatment of Early Parkinson's Disease |
05/02/2007 |
FDA Proposes New Warnings About Young Adults Taking Antidepressants |
04/30/2007 |
FDA Approves Product to Treat Common Bleeding Disorder |
04/18/2007 |
FDA Approves First U.S. Vaccine for Humans Against Bird Flu |
04/13/2007 |
FDA Approves Antibiotic Ointment for Children and Adults |
04/02/2007 |
FDA Approves First Biologic to Treat Rare Clotting Disorder |
03/16/2007 |
FDA Approves First-of-its-Kind Drug to Treat Rare Blood Disorder |
03/14/2007 |
FDA Approves Tykerb for Advanced Breast Cancer |
03/07/2007 |
FDA Approves New Drug Treatment for High Blood Pressure |
02/28/2007 |
FDA Approves New Treatment For Crohn's Disease |
02/22/2007 |
Phase III Study Results: Avastin for Advanced Lung Cancer |
02/21/2007 |
FDA Calls for ADHD Patient Medication Guides |
02/13/2007 |
Information on RotaTeq Vaccine and Intussusception |
02/12/2007 |
FDA Announces Label and Indication Changes for the Antibiotic Ketek |
02/09/2007 |
Medical Therapy for Restless Legs Syndrome May Trigger Compulsive Gambling |
02/08/2007 |
FDA Approves Orlistat for Over-the-Counter Use |
02/02/2007 |
BDSI Announces FDA Acceptance of Bioral(R) Amphotericin Investigational New Drug Application |
02/02/2007 |
GlaxoSmithKline Receives Approvable Letter for New Indications for Arixtra(R) (Fondaparinux Sodium) Injection |
02/01/2007 |
Grifols Announces FDA Approval of Alphanate(R) to Treat von Willebrand Disease |
01/30/2007 |
FDA Approves NovoLog(R) (Insulin Aspart [rDNA Origin] Injection) Category Change for Use in Pregnant Women with Type 1 Diabetes |
01/30/2007 |
Innovative Long-Acting Contraceptive Product Mirena(R) Approved in Japan |
01/29/2007 |
Pharmion Corporation Announces FDA Approval of Vidaza NDA Supplement for IV Administration |
01/29/2007 |
Tarceva: European Approval for Pancreatic Cancer Treatment Important New Therapy Option for Patients Suffering From One of the Deadliest Cancers |
01/29/2007 |
FDA Approves New Indication for YAZ(R) (3 mg drospirenone/20 mcg ethinyl estradiol) to Treat Acne |
01/26/2007 |
Study Suggests Thrombolysis Therapy With Alteplase Could Be Used Routinely for Stroke Treatment |
01/26/2007 |
Copegus Approved in Japan as Combination Therapy With Pegasys for Patients With Chronic Hepatitis C |
01/25/2007 |
FDA Advisory Committee Recommends Licensure of New Pediatric Combination Vaccine |
01/25/2007 |
Bayer Discontinues Trasylol® (Aprotinin Injection) Clinical Trial Program in Non-CABG Indications |
01/25/2007 |
Committee for Medicinal Products for Human Use Post-Authorisation Summary of Positive Opinion* for Xyrem (Sodium Oxybate) |
01/25/2007 |
Januvia™ (Sitagliptin Phosphate), First in New Class of Oral Treatments Known as DPP-4 Inhibitors, Recommended for Approval for the Treatment of Type 2 Diabetes in the European Union |
01/25/2007 |
First New Prescription Smoking Cessation Treatment Approved in a Decade |
01/24/2007 |
Lucentis(R) (Ranibizumab) Receives Approval in the European Union - The First Drug to Improve Vision in Patients With Wet AMD, a Leading Cause of Blindness |
01/23/2007 |
Wyeth Receives Approvable Letter From FDA for Pristiq (Desvenlafaxine Succinate) for the Treatment of Major Depressive Disorder |
01/23/2007 |
Stiefel Laboratories Receives FDA Approval of Olux-E (Clobetasol Propionate) Foam, 0.05% for Treatment of Psoriasis and Eczema |
01/22/2007 |
Eisai Announces Inovelon(R) (Rufinamide) Receives Marketing Authorization Approval from European Commission |
01/22/2007 |
FDA Grants Chelsea Therapeutics Orphan Drug Designation for Droxidopa |
01/18/2007 |
FDA Approves 18-Month Shelf Life for Taxus(R) Stent System |
01/18/2007 |
Cipralex Approved in Europe for Treatment of Obsessive Compulsive Disorder |
01/17/2007 |
FDA Approves Lialda(TM) (Mesalamine), the First Oral Once-Daily Mesalamine For Patients With Active, Mild to Moderate Ulcerative Colitis |
01/15/2007 |
Lux Biosciences Receives Orphan Drug Designation from the FDA for Two Ophthalmic Products |
01/10/2007 |
Neorecormon Gains European Approval for Convenient Once Weekly Treatment of Anaemia in Patients With Solid Cancers |
01/08/2007 |
FDA Approves MedImmune's Refrigerated Formulation of FluMist(R) |
01/05/2007 |
Positive and Robust Phase 2 Results for Novel Sleep Drug - HY10275 |
01/05/2007 |
Correction of Dosing Chart for the Tamiflu Oral Suspension for Prophylaxis of Influenza in Pediatric Patients |
01/03/2007 |
FDA Approves Byetta(R) (Exenatide) Injection for Expanded Combination Use |
12/29/2006 |
Boca Pharmacal Receives FDA Approval for Generic Pamine(R) and Pamine(R) Forte Tablets |
12/27/2006 |
FDA Approves Radiesse(R) Facial Filler for Two New Aesthetic Indications |
12/21/2006 |
FDA Approves New Indication for Invanz(R) (Ertapenem) for the Prevention of Surgical Site Infections (SSI) following Elective Colorectal Surgery in Adults |
12/20/2006 |
FDA Approves Treatment for Children and Teens With Mildly to Moderately Active Ulcerative Colitis |
12/20/2006 |
Positive Opinion From European Regulatory Authorities for combination use of Actos® (Pioglitazone HCl) With Insulin for Type 2 Diabetes |
12/20/2006 |
Invega(TM) (Paliperidone) Approved By FDA as New Treatment for Schizophrenia |
12/20/2006 |
Study Shows Fentanyl Iontophoretic Transdermal System Rated Comparably as Method of Pain Control to IV Patient-Controlled Morphine After Total Hip Replacement |
12/19/2006 |
FDA Proposes Labeling Changes to Over the Counter Pain Relievers |
12/19/2006 |
Trillium's TTI-1612 product receives orphan drug designation in Europe and the United States |
12/19/2006 |
FDA Grants Torisel NDA Priority Review Status |
12/19/2006 |
FDA Warns of Safety Concern Regarding Rituxan in New Patient Population |
12/18/2006 |
BioSante Pharmaceuticals Receives FDA Approval of Bio-E-Gel(R) (estradiol gel), To Be Marketed as Elestrin(TM) |
12/18/2006 |
Celebrex (Celecoxib) Approved to Treat Juvenile Rheumatoid Arthritis |
12/18/2006 |
FDA Approves Drug to Treat Cyanide Poisoning |
12/18/2006 |
FDA Approves Foradil(R) Certihaler(TM) (Formoterol Fumarate Inhalation Powder) |
12/15/2006 |
FDA Revises Labeling for Trasylol (Aprotinin Injection) to Strengthen Safety Warnings and Limit Usage of Drug to Specific Situations |
12/15/2006 |
Genta Receives Non-Approvable Notice for Application of Genasense(R) (Bcl-2 Antisense) in Patients With Chronic Lymphocytic Leukemia |
12/15/2006 |
New England Journal of Medicine Publishes Data from Pivotal Study of Avastin Plus Chemotherapy in Most Common Type of Lung Cancer |
12/15/2006 |
New Drug Offers Promise as Single Treatment for HIV |
12/15/2006 |
Multiple Myeloma Patients Respond to Retreatment with Velcade(R) (Bortezomib) for Injection |
12/08/2006 |
FDA Approves Velcade(R) (Bortezomib) for Injection for Aggressive Form of Non-Hodgkin's Lymphoma |
12/05/2006 |
Nasonex (Mometasone Furoate Monohydrate) Approved by Health Canada for Nasal Polyps |
12/01/2006 |
Eligard(R) (leuprolide acetate) 6-Month Formulation Approved in Germany |
11/30/2006 |
Solesta Receives Approval in Europe for Treatment of Fecal Incontinence |
11/30/2006 |
Abraxis BioScience Receives FDA Approval for Ampicillin and Sulbactam for Injection, 15g, USP |
11/28/2006 |
Solaraze(R) (Diclofenac Sodium)Receives Approval in Australia |
11/23/2006 |
FDA Approves Betaseron(R) (Interferon beta-1b) for Use After the First Event Suggestive of Multiple Sclerosis |
11/22/2006 |
Sprycel(TM) (Dasatinib) Approved in Europe -- The First Significant Advance for Treatment-Resistant Cml and Ph+ All Leukaemia Patients in 5 Years |
11/21/2006 |
Byetta(R) (Exenatide) Approved for Treatment of Type 2 Diabetes by European Commission |
11/21/2006 |
US FDA Grants Immtech's Oral Drug Candidate Pafuramidine (DB289) Orphan Drug Status for Treatment of PCP |
11/14/2006 |
Abbott's Humira(R) (adalimumab) Receives FDA Approval for Inhibiting Structural Joint Damage and Improving Physical Function in Patients With Psoriatic Arthritis |
11/10/2006 |
FDA Approves Mirapex (Pramipexole Dihydrochloride) for the Treatment of Moderate-to-Severe Primary Restless Legs Syndrome |
11/08/2006 |
FDA Approves Ziana(TM) (Clindamycin Phosphate 1.2% and Tretinoin 0.025%) Gel for Acne |
11/07/2006 |
Prexige (Lumiracoxib) Cleared for Approval in the European Union as a New Treatment Option for Patients Suffering From Osteoarthritic Pain |
11/03/2006 |
NovaDel Pharma Receives FDA Approval of NitroMist(TM) |
10/31/2006 |
Avanir Receives FDA Approvable Letter for Zenvia(TM) for the Treatment of Involuntary Emotional Expression Disorder |
10/31/2006 |
Alpharma Receives FDA Approval for Kadian(R) (Morphine Sulfate) 80mg Capsules |
10/25/2006 |
Tyzeka(TM) (Telbivudine) Approved By U.S. Food and Drug Administration as a New Treatment for Patients With Chronic Hepatitis B |
10/24/2006 |
FDA Approves New Formulation for Nexium (Esomeprazole Magnesium) |
10/23/2006 |
FDA Approves New Treatment for Allergies |
10/23/2006 |
FDA Approves Noxafil(R) (Posaconazole) for Treatment of Oropharyngeal Candidiasis |
10/23/2006 |
FDA Approves Desonate(TM) (Desonide) Gel 0.05% With Patented Hydrogel Technology for Treatment of Atopic Dermatitis |
10/20/2006 |
FDA Approves Reyataz(R) (Atazanavir Sulfate) 300 mg Single Capsule Formulation in Combination Therapy for Adults With HIV-1 Infection |
10/20/2006 |
FDA Approves Seroquel(R) (Quetiapine Fumarate) for Bipolar Depression Treatment |
10/20/2006 |
Gleevec(R) (Imatinib Mesylate) Approved in US for Five Rare Life-Threatening Disorders With Limited Treatment Options |
10/20/2006 |
FDA Approves Prescription Zaditor (ketotifen fumarate) Eye Drops for Over-the-Counter Relief From Itchy Eyes |
10/20/2006 |
FDA Approves Anti-Psychotic Drug Risperidone for Use in Children Diagnosed With Autism |
10/19/2006 |
FDA Approves Allegra(R) (fexofenadine hydrochloride) Oral Suspension for Treatment of Seasonal Allergy Symptoms and Chronic Idiopathic Urticaria |
10/19/2006 |
FDA Expands Remicade(R) (Infliximab) Indication for Ulcerative Colitis: Biologic Maintains Long-Term Clinical Remission and Mucosal Healing |
10/18/2006 |
FDA Approves New Treatment for Advanced Head and Neck Cancer |
10/18/2006 |
FDA Approves Once-Daily Januvia(TM) (Sitagliptin Phosphate), the First and Only DPP-4 Inhibitor Available in the United States for Type 2 Diabetes |
10/17/2006 |
FDA Approves Supplemental Use of NovoSeven(R) Coagulation Factor VIIa (Recombinant) for Treatment of Acquired Hemophilia |
10/17/2006 |
Dusa Pharmaceuticals Reports Brazilian Regulatory Approval for Levulan (Aminolevulinic Acid Hcl) Topical Solution |
10/13/2006 |
FDA Approves Expanded Use of Treatment for Patients With Severe Alzheimer's Disease |
10/13/2006 |
FDA Approves Nexium for the Treatment of Zollinger-Ellison Syndrome |
10/12/2006 |
FDA Approves Avastin(R) (Bevacizumab) in Combination With Chemotherapy for First-Line Treatment of Most Common Type of Lung Cancer |
10/10/2006 |
FDA Approves the First Drug to Treat Irritability Associated with Autism, Risperdal |
10/06/2006 |
Suboxone(R) (Buprenorphine/Naloxone) Approved in European Union for Treatment of Opioid Dependence |
10/05/2006 |
FDA Approves New Label for Vytorin(R) (Ezetimibe/Simvastatin) |
10/05/2006 |
FDA Approves FluLaval(TM) (Influenza Virus Vaccine) |
10/05/2006 |
FDA Approves New Indication for YAZ(R) (3 mg drospirenone/20 mcg ethinyl estradiol) to Treat Emotional and Physical Symptoms of Premenstrual Dysphoric Disorder |
10/04/2006 |
Health Canada Grants Approval of Tysabri(TM) (Natalizumab) for the Treatment of Multiple Sclerosis Following Priority Review |
10/04/2006 |
FDA Approves Atropine Treatment for Wider Usage |
09/30/2006 |
FDA Approves Two New Indications for Rituxan(R) (Rituximab) in Patients With Non-Hodgkin's Lymphoma |
09/29/2006 |
Lamictal (Lamotrigine) - Exposure to Medication During the First 3 Months of Pregnancy May Increase Chances of Baby Being Born With Cleft Lip or Cleft Palate |
09/29/2006 |
Pfizer's Anti-Smoking Pill Champix(R) (Varenicline) Approved in Europe |
09/29/2006 |
Labopharm Receives Approvable Letter From FDA for Once-Daily Tramadol |
09/27/2006 |
FDA Approves Remicade(R) (Infliximab) for Treatment of Chronic Severe Plaque Psoriasis |
09/26/2006 |
Cephalon Receives FDA Approval of Fentora(TM) (fentanyl buccal tablet) for the Management of Breakthrough Pain in Patients with Cancer |
09/26/2006 |
Grazax(R) Tablet-Based Vaccine Against Grass Pollen Allergy Approved in Europe |
09/26/2006 |
FDA/Genentech Warning on Avastin (Bevacizumab) |
09/25/2006 |
FDA Approves New Epilepsy Indication For Lamictal(R) (Lamotrigine) Tablets |
09/22/2006 |
European Commission Approves Gardasil(R) Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine, Merck's Cervical Cancer Vaccine |
09/22/2006 |
CDC Recommends Routine, Voluntary HIV Screening in Health Care Settings |
09/21/2006 |
FDA Warns of Serious Blood Clot Risk in Women on Ortho Evra (Norelgestromin/Ethinyl Estradiol) |
09/21/2006 |
Exjade (Deferasirox), a Breakthrough Once-Daily Oral Iron Chelator, Now Available in the UK |
09/21/2006 |
Telbivudine Approved in Switzerland for Chronic Hepatitis B |
09/20/2006 |
FDA Approves Connetics' Verdeso Foam for the Treatment of Mild-to-Moderate Atopic Dermatitis |
09/19/2006 |
Asthma Treatment Approved By Health Canada for Relief of Symptoms of Seasonal Allergic Rhinitis |
09/19/2006 |
Glivec(R) (Imatinib) Receives Additional EU Approvals for Use in Treating a Rapidly Progressive Form of Leukemia and a Hard-to-Treat Solid Cancer Tumor |
09/19/2006 |
Pfizer's Lyrica(R) (Pregabalin Capsules) Approved in Europe for Difficult-to-Treat Nerve Pain |
09/18/2006 |
FDA Approves Noxafil(R) (Posaconazole) for Prevention of Invasive Fungal Infections |
09/13/2006 |
Abraxane(TM) (Paclitaxel Powder for Injectable Suspension) Approved for Advanced Breast Cancer Treatment in Canada |
09/13/2006 |
Health Canada-Approved Treatment Reduces Potentially Fatal Chemotherapy Side-Effect by as Much as 94% |
09/07/2006 |
Orphan Designation Granted for Advexin Therapy in European Union |
09/06/2006 |
Neuprex(R) (Opebacan) Granted Orphan Status in Europe in Meningococcal Disease |
08/31/2006 |
Health Canada Approves SUTENT for Metastatic Kidney Cancer |
08/30/2006 |
Mylan Announces Tentative Approval for Fluoxetine Capsules, USP |
08/30/2006 |
Atrium Medical Corporation receives FDA approval for the iVENA(TM) Vascular Patch |
08/28/2006 |
Hydralazine HCl Voluntary Recall Due to Particulates |
08/28/2006 |
InSite Vision Announces FDA Acceptance of New Drug Application for Review |
08/25/2006 |
Health Canada Endorsed Important Safety Information on Rapamune (Sirolimus) |
08/24/2006 |
FDA Approves Over-the-Counter Access for Plan B for Women 18 and Older |
08/23/2006 |
FDA Approves Keppra(R) (Levetiracetam) as Adjunctive Therapy in the Treatment of Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy |
08/23/2006 |
Oral Rotavirus Gastroenteritis Vaccine Approved in Canada |
08/21/2006 |
Glaxo Adds Strong Heart Risk Warning to ADHD Drug |
08/21/2006 |
Health Canada Approves Azilect(R) (Rasagiline) for Parkinson's Disease |
08/18/2006 |
Eli Lilly and Company Receives Approvable Letter From FDA for Arxxant(TM) (Ruboxistaurin Mesylate) |
08/18/2006 |
Keppra(R) (Levetiracetam) Granted European Monotherapy Approval |
08/17/2006 |
FDA Approves New Medical Use for Plavix (Clopidogrel Bisulfate) |
08/16/2006 |
FDA Approves Baclofen for Spasticity in Multiple Sclerosis |
08/14/2006 |
U.S. FDA Approves Actonel for Broader Use in Men With Osteoporosis |
08/14/2006 |
FDA Expands Remicade(R) Psoriatic Arthritis Indication: Anti-TNF Shown to Inhibit Joint Damage and Improve Physical Function |
08/11/2006 |
FDA Warns Three Firms to Stop Mass-Producing Unapproved Inhalation Drugs |
08/10/2006 |
Biologic Enbrel(R) (Entanercept) Available in Easy-to-Use, Prefilled Syringe |
08/10/2006 |
Dacogen(TM) (Decitabine) for Injection Receives U.S. Orphan Drug Designation for Patients With Acute Myeloid Leukemia |
08/08/2006 |
MacuSight Announces FDA Acceptance of IND for Novel Ophthalmic Drug Candidate |
08/08/2006 |
Januvia(TM) (Sitagliptin Phosphate) Receives Approval in Mexico |
08/03/2006 |
Betaferon(R) (Interferon beta-1b) Approved in Canada for Treatment of the Earliest Stages of Multiple Sclerosis |
08/03/2006 |
FDA Approves Influenza Vaccines to be Manufactured for Upcoming Flu Season |
08/02/2006 |
European Commission Approves ATryn(R) (recombinant human antithrombin) |
08/02/2006 |
Baxter Receives Health Canada Approval for Advate(R) [Antihemophilic Factor (Recombinant) |
08/02/2006 |
FDA Approves Keppra(R) (Levetiracetam) Intravenous Formulation |
07/31/2006 |
Novo Nordisk Receives Approval in EU for Use of NovoRapid(R) (Insulin Aspart) in Pregnancy |
07/31/2006 |
Merck Announces FDA Acceptance of New Drug Application for MK-0431A, an Investigational Fixed Dose Combination of Januvia(TM) and Metformin for Type 2 Diabetes |
07/31/2006 |
FDA Approves duetact(TM) (pioglitazone HCl and glimepiride) for the Treatment of Type 2 Diabetes |
07/31/2006 |
Temodal (Temozolomide) Approved by Japan's Ministry of Health, Labor and Welfare for Patients With Malignant Gliomas |
07/31/2006 |
Humira (Adalimumab) Receives FDA Approval for Treatment of Ankylosing Spondylitis |
07/31/2006 |
Health Canada Approves First New Advanced Kidney Cancer Treatment in More Than a Decade |
07/31/2006 |
Ovarian Cancer Drug Combination Identified at Rational Therapeutics Receives FDA Approval |
07/31/2006 |
FDA Approves Supplemental New Drug Application for Antiviral Treatment Famvir(R) (Famciclovir) |
07/31/2006 |
FDA Approves Xolegel(TM) Gel for Treatment of Seborrheic Dermatitis |
07/31/2006 |
Glivec(R) (Imatinib) Receives Positive European Union Opinion for Treatment of Rare, Potentially Life-Threatening Cancers With Limited Treatment Options |
07/28/2006 |
Cervical Cancer Vaccine Receives Positive Opinion From European Medicines Agency |
07/27/2006 |
European Commission Grants Conditional Marketing Authorization To Pfizer's Sutent® (Sunitinib Malate) |
07/27/2006 |
Vegamox(TM) (Moxifloxacin Hydrochloride Ophthalmic Solution) Approved in Japan for Eye Infections |
07/27/2006 |
Patanol(R) (Olopatadine Hydrochloride Ophthalmic Solution), Approved in Japan for Allergic Conjunctivitis |
07/27/2006 |
New Test Could Keep Babies From Contracting Deadly Infections |
07/26/2006 |
FDA Grants Orphan Drug Designation to Allos Therapeutics' Novel Antifolate PDX (Pralatrexate) for Treatment of T-cell Lymphoma |
07/25/2006 |
FDA Approves Oncaspar for Newly-Diagnosed Acute Lymphoblastic Leukemia |
07/24/2006 |
Shire's Elaprase (Idursulfase) Approved by FDA for Hunter Syndrome |
07/24/2006 |
First and Only Oral Medication Approved for Pulmonary Arterial Hypertension in HIV Patients |
07/24/2006 |
Nexavar (Sorafenib) Approved by European Commission for the Treatment of Advanced Kidney Cancer |
07/23/2006 |
Anti-EGFr Drug Nimotuzumab Approved in India for Head and Neck Cancer |
07/22/2006 |
Liposome Vaccine Prostate Cancer Study Results Published |
07/22/2006 |
Betamethasone Foam Demonstrates High Efficacy in Psoriasis Treatment and 85% Better Usability than Cream |
07/22/2006 |
Nexavar (Sorafenib) Receives FDA Fast Track Designation for Skin Cancer |
07/21/2006 |
FDA Approves Single-Rod Implantable Contraceptive |
07/21/2006 |
Health Canada Approves First and Only Vaccine to Prevent Cervical, Vulvar and Vaginal Cancer as Well as Genital Warts |
07/21/2006 |
Valeant Pharmaceuticals Announces Availability of Zelapar(R) for Parkinson's Disease Patients |
07/21/2006 |
Nabi Biopharmaceuticals Releases New Data which Demonstrate Superior Serum Phosphorus Control with PhosLo® (calcium acetate) Over Sevelamer |
07/21/2006 |
Cimzia Shows Promise in Treatment of Psoriasis |
07/17/2006 |
FDA Approves Lilly's Gemzar (Gemcitabine HCl) for Ovarian Cancer Treatment |
07/14/2006 |
Multiple Myeloma Oral Therapy Revlimid (Lenalidomide) Approved by FDA |
07/13/2006 |
New UK Licence Indication for Arimidex (Anastrozole) Extends Benefits to More Adjuvant Patients With HR+ Early Breast Cancer |
07/12/2006 |
U.S. FDA Approves Atripla (Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate), First Once-Daily Single Tablet Regimen for Adults With HIV-1 Infection |
07/11/2006 |
Mabthera Approved for Use in Rheumatoid Arthritis in Europe |
07/11/2006 |
Mabthera Approved in Europe for Maintenance Therapy in Patients With Common Form of Lymphoma |
07/11/2006 |
FDA Approves Emend (Aprepitant), Merck's Antiemetic Therapy, for the Prevention of Postoperative Nausea and Vomiting |
07/11/2006 |
FDA Approves Avandamet (Rosiglitazone Maleate and Metformin HCl) as Initial Therapy in the Treatment of Type 2 Diabetes |
07/10/2006 |
European Commission Approves Revision of Therapeutic Indication for Rebif (interferon beta-1a) |
07/07/2006 |
ZARS Pharma Announces FDA Approval of a Topical Local Anesthetic Peel (Lidocaine and Tetracaine) 7%/7% |
07/04/2006 |
Health Canada Endorsed Important Safety Information on Anzemet (Dolasetron Mesylate) |
07/03/2006 |
New Tablet Formulation of Kaletra (Lopinavir/Ritonavir) Approved in Europe |
07/03/2006 |
FDA Grants Tentative Approval of a Three-Component AIDS Drug |
06/30/2006 |
FDA Approves Lucentis for the Treatment of Wet Age-Related Macular Degeneration |
06/30/2006 |
Revlimid in Combination With Dexamethasone sNDA Granted Approval By FDA for Treatment of Multiple Myeloma |
06/30/2006 |
Cephalon Receives Approvable Letter for Fentora(TM) (fentanyl buccal tablet) for Management of Breakthrough Pain in Patients with Cancer |
06/29/2006 |
FDA Approves Sprycel (Dasatinib) With Two Indications |
06/29/2006 |
Tysabri (Natalizumab) Receives Approval in European Union for Treatment of Relapsing Remitting Forms of Multiple Sclerosis |
06/29/2006 |
Wyeth Receives Approvable Letter From the FDA for Lybrel |
06/28/2006 |
The U.S. Food and Drug Administration Approves Exelon(R) (rivastigmine tartrate) as the First Medication Indicated to Treat Parkinson's Disease Dementia |
06/28/2006 |
EntreMed Granted Orphan Drug Designation for Panzem(R) (2ME2) In Glioblastoma |
06/26/2006 |
Lupin Receives Final Approval for Quinapril Tablets |
06/26/2006 |
FDA Approves First Generic Simvastatin |
06/26/2006 |
FDA Approves New HIV Treatment for Patients Who Do Not Respond to Existing Drugs |
06/23/2006 |
Genaera Receives Patent for Gene Variants of Interleukin-9 Receptor |
06/23/2006 |
Penwest Announces That Endo Reports Receiving Final FDA Approval for Oxymorphone ER - Pain Relief Product Expected to Be Commercially Available in the U.S. in the Coming Weeks Under Trade Name Opana(R) ER - |
06/23/2006 |
Endo Receives FDA Approval for Opana(R) ER (oxymorphone HCl) Extended-Release and Opana(R) (oxymorphone HCl) Immediate Release Tablets CII |
06/21/2006 |
FDA Approves Avastin (Bevacizumab) in Combination With Chemotherapy for Second-Line Metastatic Colorectal Cancer Patients |
06/21/2006 |
Elusys' Anthrax Therapeutic, Anthim, Granted FDA Orphan Drug Designation |
06/16/2006 |
Baxter Receives Tentative FDA Approvals for Ondansetron Injection in Vials and Premix Containers |
06/15/2006 |
Discovery Labs' Surfaxin Granted Orphan Drug Designation for the Prevention of Bronchopulmonary Dysplasia |
06/15/2006 |
GlaxoSmithKline Announces Expanded Indication for Hycamtin (Topotecan HCl) to Treat Cervical Cancer in Combination Chemotherapy New Indication Based on Survival |
06/14/2006 |
Health Canada Approves Treatment for Anemia-Related Fatigue in Chemotherapy Patients |
06/14/2006 |
Pharming Receives Orphan Drug Designations for rhC1INH From U.S. FDA |
06/13/2006 |
Vivitrol, the First, Once-Monthly Injectable Medication for Alcohol Dependence Now Available in the United States |
06/13/2006 |
Nexavar Receives Fast Track Designation from the FDA for Metastatic Liver Cancer |
06/13/2006 |
Saforis NDA Accepted by U.S. FDA for Priority Review |
06/12/2006 |
FDA Approves the First Drug for Seasonal Depression |
06/09/2006 |
Pozen Inc. and GlaxoSmithKline Report Receipt of Approvable Letter for Investigational Migraine Treatment |
06/09/2006 |
FDA Approves New Indication for Zetia (Ezetimibe) |
06/09/2006 |
Hana Biosciences Receives Orphan Drug Designation for Ropidoxuridine (IPdR), for the Treatment of Malignant Glioma |
06/08/2006 |
Health Canada Approves Remicade (Infliximab) for Psoriasis and Psoriatic Arthritis |
06/08/2006 |
FDA Approves Merck's Gardasil®, the World's First and Only Cervical Cancer Vaccine |
06/07/2006 |
Betaferon (Interferon Beta-1b) Approved in Europe as a First-Line Treatment for the Earliest Stages of Multiple Sclerosis |
06/07/2006 |
EU Approval Marks Third for Humira in Treating Autoimmune Diseases |
06/06/2006 |
Alliant Pharmaceuticals Announces Return of Chewable Tablets for ADHD |
06/06/2006 |
Aspreva and Roche Receive Orphan Drug Designation from FDA for Evaluation of CellCept in Rare Autoimmune Disease Pemphigus Vulgaris |
06/06/2006 |
Xechem Receives Orphan Drug Designation From The FDA For Its Anti-Sickling Drug 5-HMF |
06/06/2006 |
Health Canada Further Restricts the Indication of Iressa (Gefitinib) to Patients Currently Benefiting From Iressa Treatment and Whose Tumours Are EGFR Positive or Unknown |
06/05/2006 |
FDA Approves Resumed Marketing of Tysabri (Natalizumab) Under Special Distribution Program |
06/02/2006 |
BioMarin and Alliant Announce FDA Approval of Orapred ODT |
06/02/2006 |
Preliminary Results from a Phase 3b Study Showed Patients With Wet AMD Treated With Ranibizumab Quarterly Experienced a 16-Letter Benefit Over the Control Group at 1 Year |
06/01/2006 |
Astellas Launches Vesicare (Solifenacin Succinate) for Treatment of Overactive Bladder in Japan |
06/01/2006 |
Isis Pharmaceuticals Receives Orphan Drug Status for ISIS 301012 for the Treatment of Homozygous Familial Hypercholesterolemia |
06/01/2006 |
Evoltra (Clofarabine) Approved in Europe for Relapsed or Refractory Acute Lymphoblastic Leukaemia |
05/31/2006 |
Updated Product Information for Efexor |
05/31/2006 |
European Commission Grants Orphan Medicinal Product Designation to Increlex for the Treatment of Primary Insulin-Like Growth Factor-1 Deficiency |
05/31/2006 |
Sandoz Gets Precedent-Setting US Approval for Omnitrope as First Follow-on Version of a Previously Approved Recombinant Biotechnology Drug |
05/26/2006 |
New Cautions Regarding Rare Heart-Related Risks for All ADHD Drugs |
05/26/2006 |
FDA Approves Expanded Label for IV Antibiotic Cubicin® (Daptomycin for Injection) |
05/26/2006 |
Thalomid sNDA Granted FDA Approval For Treatment of Newly Diagnosed Multiple Myeloma |
05/26/2006 |
FDA Approves Seasonique(TM) Extended-Cycle Oral Contraceptive |
05/26/2006 |
FDA Licenses New Vaccine to Reduce Older Americans' Risk of Shingles |
05/25/2006 |
Iplex Available in U.S. for Children With Severe Short Stature |
05/25/2006 |
Allergan Receives Pan European License for Bimatoprost/Timolol Ophthalmic Solution From European Commission |
05/25/2006 |
Health Canada Endorses Important Safety Information on Evista (Raloxifene Hydrochloride) |
05/23/2006 |
CEL-SCI Presents Long-Term Survival Data With Its Anti-Cancer Drug |
05/23/2006 |
ALZA Corporation Receives FDA Approval for Ionsys (Fentanyl Iontophoretic Transdermal System) |
05/23/2006 |
Focalin XR Receives FDA Approval of New Labeling Information in Attention-Deficit/Hyperactivity Disorder |
05/22/2006 |
FDA Approves Remicade (infliximab) as First and Only Biologic Treatment for Children With Active Crohn's Disease |
05/19/2006 |
Spectrum Laboratory Products Recalls Tacrolimus Active Pharmaceutical Ingredient [API] |
05/19/2006 |
Parkinson's Drug Receives FDA Approval |
05/19/2006 |
First Over-the-Counter Migraine Pill Available in UK |
05/18/2006 |
Bristol-Myers Squibb Announces Discontinuation of Development of Muraglitazar, an Investigational Oral Treatment for Type 2 Diabetes |
05/17/2006 |
FDA Approves Azilect (Rasagiline Tablets) for Parkinson's Disease |
05/17/2006 |
Updated safety information for Tequin (Gatifloxacin) and Serious Hypoglycemia and Hyperglycemia |
05/17/2006 |
Coley's Actilon for Chronic Hepatitis C Virus Therapy Granted |
05/17/2006 |
Exemestane Becomes the First And Only Aromatase Inhibitor for Adjuvant Sequential Therapy in Early-Stage Breast Cancer |
05/17/2006 |
New Long-Acting Insulin Analog Levemir (Insulin Detemir [rDNA Origin] Injection) Available in United States |
05/16/2006 |
Valeant Receives FDA Marketing Approval for Cannabinoid Cesamet(TM) (CII) |
05/16/2006 |
Neurocrine Receives Approvable Letter for Indiplon Capsules and Non-Approvable for Indiplon Tablets for Treatment of Insomnia |
05/15/2006 |
Advancis Pharmaceutical Receives FDA Approval Letter for New Strengths of Antibiotic Keflex(R) |
05/12/2006 |
One Lot of Minitran Transdermal System 0.6 Mg/Hr (Nitroglycerin) Recalled By Manufacturer |
05/12/2006 |
Changes to Warnings on Paroxetine |
05/11/2006 |
WHO Announces Pharmaceutical Companies Agree to Stop Marketing Single-Drug Artemisinin Malaria Pills |
05/11/2006 |
FDA Approves Novel Medication for Smoking Cessation |
05/10/2006 |
Boston Scientific and BioForm Medical Announce FDA Approval of Injectable Implant |
05/10/2006 |
Green Light in Europe for Schering's New Low-Dose Contraceptive |
05/10/2006 |
Cell Genesys Receives Fast Track Status for Immunotherapy for Prostate Cancer |
05/09/2006 |
Lilly Submits Supplemental New Drug Application for Generalized Anxiety Disorder |
05/08/2006 |
Introgen's Advexin p53 Therapy Provided to Cancer Patients With Li-Fraumeni Syndrome |
05/08/2006 |
Roche Releases Guidelines for Consumers on How to Avoid Counterfeit Flu Drug |
05/08/2006 |
Femara Endorsed Post-Surgery for Women With Early Breast Cancer in Scotland |
05/08/2006 |
Duramed's Enjuvia (Synthetic Conjugated Estrogens, B) Now Available in U.S. Pharmacies |
05/05/2006 |
USAN Council Approves Nonproprietary Name Lorcaserin Hydrochloride for Arena Drug Candidate APD356 |
05/04/2006 |
Pfizer's Genotropin (Somatropin [rDNA origin] for Injection) Approved in The U.S. for Treatment of Growth Failure Associated With Turner Syndrome |
05/03/2006 |
GSK Receives Positive Opinion From CHMP on Seretide (Salmeterol/Fluticasone Propionate) Dosing for Initial Maintenance Therapy |
05/03/2006 |
U.S. FDA Approves Dacogen (Decitabine) for Injection |
05/02/2006 |
New Broad-Spectrum Antibiotic Tygacil (Tigecycline) Receives Approval for Use in Europe |
05/02/2006 |
Novo Nordisk Receives EU Approval for NovoMix® 30 (Biphasic Insulin Aspart) Label Extension |
05/01/2006 |
Intravenous Form and Labeling Approved for Ibandronate: Presented at AACE |
04/28/2006 |
FDA Approves Genzyme's Myozyme (Alglucosidase Alfa) for All Patients with Pompe Disease |
04/28/2006 |
SkyePharma Announces First European Approval of DepoDur |
04/28/2006 |
Acomplia (Rimonabant) Recommended for Approval in the European Union |
04/28/2006 |
CHMP Issues Positive Opinion for Tysabri (Natalizumab) as a Treatment for Relapsing-Remitting Multiple Sclerosis |
04/28/2006 |
Herceptin Receives Positive Opinion in Europe for Early Use in HER2-Positive Breast Cancer |
04/28/2006 |
Nexavar Receives Positive Opinion from European Committee for Medicinal Products for Human Use |
04/28/2006 |
Humira (Adalimumab) Receives Positive Opinion From European Medicines Agency for the Treatment of Ankylosing Spondylitis |
04/28/2006 |
Pfizer's Sutent Receives Positive Opinion in the European Union For Two Difficult-To-Treat Advanced Cancers |
04/28/2006 |
New Tablet Formulation of Kaletra (Lopinavir/Ritonavir) Receives Positive Opinion From the European Medicines Agency |
04/27/2006 |
Astellas Launches Vaprisol for Treatment of Euvolemic Hyponatremia in Hospitalized Patients |
04/26/2006 |
FDA Grants Orphan Drug Designation to Nexavar (Sorafenib) for the Treatment of Hepatocellular Carcinoma |
04/26/2006 |
European Commission Issues Marketing Authorization for Preotact (Parathyroid Hormone for Injection) |
04/26/2006 |
Depomed and Esprit Announce Availability of ProQuin XR (Ciprofloxacin Hydrochloride) 3-Tablet Blister Packs |
04/26/2006 |
EU Label Change for Intron A (Interferon Alfa-2b) Incorporates Long-Term Efficacy Data in Patients with Chronic Hepatitis C |
04/25/2006 |
Astex Therapeutics Announces IND Approval For Novel Cancer Drug AT9283 |
04/25/2006 |
Amitiza (Lubiprostone), the First Selective Chloride Channel Activator for the Treatment of Chronic Idiopathic Constipation, Launches in the United States |
04/24/2006 |
Higher Dose Copegus (Ribarivin) 400mg Tablets Approved in the Netherlands as First Step to European Availability |
04/20/2006 |
AEterna Zentaris Gains Market Approval for Cetrotide (cetrorelix) in Japan for In Vitro Fertilization |
04/20/2006 |
FDA Grants Fast Track Designation to Schering-Plough for its Thrombin Receptor Antagonist |
04/19/2006 |
New Oral Contraceptive Available in the United States |
04/18/2006 |
European Commission Grants Orphan Medicinal Product Designation to Nexavar for the Treatment of Hepatocellular Carcinoma |
04/18/2006 |
Neurochem announces eprodisate (Fibrillex) NDA filed and granted priority review by FDA for the treatment of AA amyloidosis |
04/18/2006 |
TheraQuest Receives FDA Fast Track Designation for Tramadol ER in Painful HIV-associated Neuropathy |
04/11/2006 |
European Regulatory Committee Recommends Orphan Medicinal Product Designation for Amigal (migalastat hydrochloride) for Fabry Disease |
04/10/2006 |
Euflexxa Labeling Extended to Include Room Temperature Storage |
04/10/2006 |
FDA Grants Priority Review of Remicade for Treatment of Children With Active Crohn's Disease |
04/07/2006 |
Adartrel (Ropinirole) Becomes First RLS Treatment to Receive Positive Decision From the European Commission |
04/07/2006 |
Shire's Daytrana Transdermal Patch Approved by FDA for Treatment of ADHD |
04/07/2006 |
Boehringer Ingelheim's Sifrol/Mirapexin (Pramipexole) First Treatment for Restless Legs Syndrome to Be Approved Throughout European Union |
04/04/2006 |
Avanir's Neurodex NDA Accepted with Priority Review for Involuntary Emotional Expression Disorder |
04/04/2006 |
FDA Grants Priority Review of Remicade (Infliximab) for the Treatment of Children with Active Crohn's Disease |
04/04/2006 |
Cephalon Oncology Compound Lestaurtinib (CEP-701) Granted Orphan Drug Designation for Acute Myeloid Leukemia |
04/04/2006 |
Samaritan's Marketing Authorization Application for Amphocil Approved in Greece |
04/04/2006 |
FDA Grants Edison's EPI-A0001 Orphan Drug Designation for Inherited Mitochondrial Respiratory Chain Diseases |
04/03/2006 |
European Commission Approves First Treatment for Pompe Disease |
04/03/2006 |
Taclonex New Dual-Action Topical Therapy for Plaque Psoriasis Now Available for Prescription |
03/31/2006 |
Prestwick Pharmaceuticals Receives FDA Approvable Letter for Xenazine (Tetrabenazine) for Treatment of Chorea Associated with Huntington's Disease |
03/31/2006 |
Roche Says E.U. Approves Bonviva (Ibandronate) as Quarterly Treatment |
03/31/2006 |
FDA Approves Prograf (Tacrolimus) to Prevent Rejection of Heart Transplant |
03/30/2006 |
First Biologic Therapy Approved in Canada for Painful Inflammatory Bowel Disease |
03/30/2006 |
PTC Therapeutics Receives Fast Track Designation for PTC124 in the Treatment of Duchenne Muscular Dystrophy |
03/30/2006 |
Nexavar Approved in Switzerland for the Treatment of Patients with Advanced Kidney Cancer |
03/29/2006 |
Innovative Osteoporosis Treatment, Fosavance, Integrates Two Essential Elements of Treatment -- Medication and Vitamin D in a Single Once-Weekly Tablet |
03/29/2006 |
FDA Approves a Second Drug for the Prevention of Influenza A and B in Adults and Children |
03/28/2006 |
Health Canada Approves Xeloda (Capecitabine) for Adjuvant Therapy in the Treatment of Colon Cancer |
03/28/2006 |
Cephalon Granted Six Months of Pediatric Exclusivity for Provigil (Modafinil) |
03/27/2006 |
Santarus Receives FDA Approval for Zegerid With Magnesium Hydroxide Chewable Tablets |
03/27/2006 |
Crucell Announces Product Approval in Korea for Quinvaxem Vaccine |
03/27/2006 |
European Medicines Agency Recommends Cautious Use of Protopic/Protopy and Elidel |
03/27/2006 |
FDA Approves Extended Dosing of Aranesp (Darbepoetin Alfa) to Treat Chemotherapy-Induced Anemia |
03/27/2006 |
Pfizer's Lyrica (Pregabalin) Approved for Treatment of Generalized Anxiety Disorder (GAD) in Europe |
03/24/2006 |
Allergan Receives Positive Opinion for Ganfort (Lumigan/Timolol Combination) in European Union |
03/24/2006 |
New Dosages of Risperdal (Risperidone) Now Available |
03/24/2006 |
FDA Advisory Committee Recommends Against Approval of Sparlon for Attention Deficit/Hyperactivity Disorder in Children and Adolescents |
03/23/2006 |
Taxotere (Docetaxel) Receives U.S. FDA Approval For Use In Advanced Stomach Cancer |
03/23/2006 |
Aastrom Biosciences Receives Orphan Drug Designation from the FDA for Proprietary Bone Marrow Cells |
03/23/2006 |
Pharmaxis' First Product, Aridol, Approved by Therapeutic Goods Administration |
03/23/2006 |
Remicade Approved in Australia for Treatment of Early Rheumatoid Arthritis and Psoriatic Arthritis |
03/23/2006 |
FDA Approves Flovent HFA (fluticasone propionate HFA) Inhalation Aerosol for Children Four to Eleven |
03/22/2006 |
Study Shows Levitra Treats Erectile Dysfunction Effectively in Men Taking Medications to Lower High Blood Pressure |
03/22/2006 |
Pixantrone Combination Regimen Produces High Rates of Complete Remission for Patients With Aggressive NHL Who Fail CHOP Therapy |
03/22/2006 |
Avicena Compound Receives Orphan Drug Designation for Huntington's Disease |
03/21/2006 |
FDA Approves Expanded Label Indication and Satisfaction of Subpart H Accelerated Approval Commitment for Remodulin (Treprostinil Sodium) Injection |
03/20/2006 |
Femara (letrozole) Approved in Germany as Initial Therapy for Postmenopausal Women With Early Breast Cancer After Surgery |
03/17/2006 |
FDA Approves YAZ(R), the First Oral Contraceptive to Offer Drospirenone in a 24-Day, Active-Pill Regimen |
03/16/2006 |
Phase 1/2 Clinical Data Demonstrate Safety and Antitumor Activity of Introgen's Advexin in Patients With Advanced Esophageal Cancer |
03/16/2006 |
Chiron Recalls and Withdraws Morupar(R) MMR Vaccine from Italian and Developing World Markets |
03/16/2006 |
Myriad Genetics' Follow-on Study of Flurizan Demonstrates Continued Benefit in Alzheimer's Disease |
03/15/2006 |
Up to Half of Metabolic Improvement Seen With Rimonabant Is Attributable to Drug Rather Than Weight-Loss Alone: Presented at ACC |
03/15/2006 |
Roche Canada resumes Tamiflu distribution |
03/15/2006 |
Novo Nordisk Receives Positive Opinion for Label Extension for Novomix 30 in Europe |
03/10/2006 |
NPS Receives Approvable Letter for PREOS New Drug Application |
03/10/2006 |
Advisory - Newer Antidepressants Linked to Serious Lung Disorder in Newborns |
03/09/2006 |
Gliadel Wafer Demonstrates Long-Term Survival Benefit for Patients With High-Grade Malignant Gliomas |
03/09/2006 |
Remicade Is First Biologic Approved in European Union to Treat Ulcerative Colitis |
03/08/2006 |
U.S. FDA Grants Traditional Approval for Gilead's Once-Daily HIV Medications Truvada (emtricitabine and tenofovir disoproxil fumarate) and Viread (tenofovir disoproxil fumarate) |
03/08/2006 |
Exelon granted EU marketing authorization as first treatment for dementia associated with Parkinson's disease by European Commission |
03/02/2006 |
Wyeth Pharmaceuticals' Antibiotic Tygacil (Tigecycline) Receives 'Positive Opinion' From European Regulatory Authority |
03/02/2006 |
FDA MedWatch - Tracleer (Bosentan): Recommended Dosage Adjustment and Monitoring Guidelines to Avoid Hepatotoxicity |
03/02/2006 |
FDA Approves Erbitux (Cetuximab), First Head & Neck Cancer Treatment in 45 Years |
03/02/2006 |
FDA MedWatch - Cefazolin for Injection Recalled Due to Microbial Contamination of Active Ingredient |
03/01/2006 |
FDA Approves Rituxan (Rituximab), the First Targeted B-Cell Therapy for Treatment of Moderate-to-Severe Rheumatoid Arthritis |
02/28/2006 |
Bayer Issues Letter to Health Care Professionals in Canada Regarding Trasylol (Aprotinin) |
02/28/2006 |
Santarus Receives FDA Approval for Zegerid Capsules; First and Only Immediate-Release Proton Pump Inhibitor in Convenient Capsule Form |
02/28/2006 |
FDA Approves Emsam (selegiline transdermal system), the First Transdermal Patch for the Treatment of Major Depressive Disorder |
02/27/2006 |
Rotarix: First Vaccine Against Rotavirus Available in Europe |
02/27/2006 |
Novartis Receives Approvable Letter from FDA for Aclasta (Zoledronic Acid 5 mg) in Treatment of Paget's Disease of the Bone |
02/27/2006 |
Novartis Receives Approvable Letter from FDA for Aclasta (Zoledronic Acid 5 mg) in Treatment of Paget's Disease of the Bone |
02/24/2006 |
Alcon Receives Positive Opinion for DuoTrav Eye Drops Solution from CHMP |
02/24/2006 |
Clofarabine Receives Positive Opinion From European Medicines Agency |
02/23/2006 |
CHMP Recommends Authorization to Market Preotact (PREOS) in Europe |
02/23/2006 |
Otsuka Maryland Research Institute, Inc. Granted Fast Track Designation for Tolvaptan in Polycystic Kidney Disease |
02/23/2006 |
Merck KGaA Receives EMEA Positive Opinion for Erbitux in Head and Neck Cancer Recommending Approval in the EU |
02/22/2006 |
Clinical Data Receives FDA 510(k) Clearance for Nanopia Wide Range CRP Assay |
02/22/2006 |
Progenics Pharmaceuticals' HIV Drug, PRO 140, Receives FDA Fast-Track Designation |
02/21/2006 |
Once Daily Ultram ER Extended-Release Tablets Now Available in the United States |
02/21/2006 |
Pfizer Receives FDA Approval for Eraxis (Anidulafungin) to Treat Candidemia, a Potentially Life-Threatening Bloodstream Infection |
02/21/2006 |
Viragen's Multiferon Approved in Sweden for First-Line Adjuvant Treatment of Malignant Melanoma |
02/20/2006 |
FDA Approves New Oral Contraceptive Loestrin 24 Fe (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets) |
02/20/2006 |
Sanofi-aventis Received from the FDA an Approvable Letter for Rimonabant for Weight Management and a Non Approvable Letter for Smoking Cessation |
02/17/2006 |
Health Canada Advises Diabetic Patients Not to Use the Antibiotic Tequin (Gatifloxacin) |
02/17/2006 |
Alvesco (Ciclesonide) Additionally Approved for Adolescents in Europe for All Severities of Persistent Asthma |
02/16/2006 |
Stronger Warnings for Tequin (gatifloxacin) |
02/16/2006 |
FDA Alerts Healthcare Professionals About Nimodipine (Nimotop) Boxed Warning |
02/15/2006 |
Risk of Serious Harm and/or Death With Potential IV/SC Administration of Fluphenazine Due to Mislabelled Octreotide Vials |
02/15/2006 |
Tysabri Multiple Sclerosis Clinical Trial Hold Lifted by FDA; Biogen Idec and Elan to Resume Clinical Trial Dosing in Multiple Sclerosis |
02/15/2006 |
Amicus Therapeutics' AT2101 Granted Orphan Drug Designation for the Treatment of Gaucher Disease |
02/14/2006 |
Caduet (Amlodipine Besylate/Atorvastatin calcium), First Pill to Treat High Blood Pressure and High Cholesterol at the Same Time |
02/14/2006 |
AstraZeneca Decides to Withdraw Exanta (Melagatran/Ximelagatran) |
02/14/2006 |
TolerRx Receives Orphan Drug Designation from FDA for TRX4 for Treatment of New-Onset Type 1 Diabetes |
02/14/2006 |
FDA Grants Orphan Drug Designation to First Amphotericin B Inhalation Powder to Prevent Pulmonary Fungal Infections in Immunosuppressed Patients |
02/13/2006 |
FDA-Requested Recall of Cytosol Laboratories' Balanced Salt Solution Due to Dangerous Levels of Endotoxin |
02/13/2006 |
FDA Issues Public Health Advisory About Benzocaine Sprays |
02/13/2006 |
Morphotek Announces FDA Acceptance of the IND for MORAb-009, a Monoclonal Antibody for the Treatment of Mesothelin-Expressing Cancers |
02/13/2006 |
YM BioSciences Receives FDA Fast Track Designation for Tesmilifene in Advanced Breast Cancer |
02/10/2006 |
FDA Approves Rituxan (Rituximab) Plus CHOP or Other Anthracycline-Based Chemotherapy Regimens for First-Line Treatment of Diffuse Large B-cell Non-Hodgkin's Lymphoma |
02/09/2006 |
Health Canada Approves Enbrel (Etanercept) for Psoriasis treatment |
02/08/2006 |
FDA Issues Public Health Advisory for Trasylol (Aprotinin Injection) |
02/08/2006 |
New Long-Acting Insulin, Levemir, Shows Less Weight Gain Associated With Insulin Therapy - Now Available In Canada |
02/08/2006 |
Xyotax (Paclitaxel Poliglumex) has FDA Fast Track Designation for Women With Advanced Lung Cancer Who Are Performance Status 2 |
02/07/2006 |
Class 2 Medicines Recall for Nitrocine |
02/07/2006 |
Antibiotic Ketek (Telithromycin) and Possible Association With Liver Failure |
02/07/2006 |
FDA Grants Fast Track Status for ViroPharma's Maribavir for Prevention of Cytomegalovirus Infection |
02/06/2006 |
TheraQuest's Abuse Deterrent Tramadol ER IND for Neuropathic Pain Accepted by FDA |
02/03/2006 |
FDA Approves Merck's Rotateq, the Only Vaccine in the U.S. to Prevent Rotavirus Gastroenteritis, a Leading Cause of Severe Infant Diarrhea |
02/03/2006 |
UCB Receives EMEA Positive Opinion and FDA Approvable Letter for Keppra (levetiracetam) Intravenous Administration |
02/02/2006 |
OSI Pharmaceuticals Announces European Regulatory Approval for Macugen (Pegaptanib Sodium Injection); First Treatment for Neovascular (Wet) Age-related Macular Degeneration |
02/02/2006 |
FDA Approves New Formulation of Imitrex (Sumatriptan Succinate) Injection |
02/02/2006 |
FDA Grants Fast Track Designation for the Investigation of Zactima (ZD6474) for Treatment of Thyroid Cancer |
02/02/2006 |
Nabi Biopharmaceuticals Announces U.S. Fast Track Designation for Civacir to Prevent Hepatitis C Re-infection in Liver Transplants |
02/02/2006 |
Health Canada Approves Temodal (Temozolomide) for Patients With Newly Diagnosed Glioblastoma Multiforme |
02/02/2006 |
FDA Approves Clarinex-D 12 Hour (Desloratadine/Pseudoephedrine) Tablet Prescription Antihistamine with Decongestant for Seasonal Allergy Sufferers |
02/01/2006 |
European Commission Approves IV Hycamtin (Topotecan Powder for Concentrate for Solution for Infusion) for Relapsed Small Cell Lung Cancer |
02/01/2006 |
Genzyme Granted Label Change for Thyrogen |
02/01/2006 |
ActivBiotics Receives FDA Fast Track Status for Rifalazil in Peripheral Arterial Disease |
02/01/2006 |
GlaxoSmithKline Announces the Approval and Availability of Avandaryl(TM) (Rosiglitazone Maleate and Glimepiride) |
02/01/2006 |
FDA Approves Ranexa (Ranolazine) for Chest Pain |
01/31/2006 |
FDA Approves New Prescription Drug for Adults for Treatment of Chronic "Idiopathic" Constipation |
01/31/2006 |
FDA Requests Nimodipine (Nimotop) Label Change |
01/31/2006 |
Tamiflu Gains Approval in Europe for Prevention of Influenza in Children Aged 1 to 12 Years |
01/31/2006 |
U.S. FDA Approves Cangene's Anti-hepatitis B Product |
01/31/2006 |
Schering-Plough Reports FDA Grants Fast Track Designation to Oral HCV Protease Inhibitor SCH 503034 |
01/31/2006 |
BioMarin Receives Marketing Approval for Naglazyme in European Union |
01/30/2006 |
European Commission Approves Ionsys (Fentanyl HCl Iontophoretic Transdermal System) for Acute Post-operative Pain |
01/30/2006 |
European Union's CHMP Recommends Approval of Exelon (Rivastigmine Tartrate) as First Symptomatic Treatment of Mild to Moderately Severe Dementia Associated With Idiopathic Parkinson's Disease |
01/30/2006 |
European Union CHMP Recommends Approval of Remicade for Treatment of Moderately to Severely Active Ulcerative Colitis |
01/30/2006 |
ISTA Pharmaceuticals Receives FDA Approval for Expanded Indication of Xibrom to Treat Pain Following Cataract Surgery |
01/27/2006 |
FDA Approves Exubera (inhaled human insulin), First Ever Inhaled Insulin Combination Product for Treatment of Diabetes |
01/27/2006 |
European Positive Opinion For First Quarterly I.V. Injection For Postmenopausal Osteoporosis |
01/27/2006 |
Pfizer's Lyrica Receives Positive Opinion From CHMP for the Treatment of Generalized Anxiety Disorder in Adults |
01/27/2006 |
Health Canada Warns Consumers of Recall of Octreotide Acetate Omega 500 mcg/mL Due to Possible Mislabelling |
01/27/2006 |
Myozyme Receives Positive Opinion from European Regulatory Committee |
01/27/2006 |
Association of WinRho SDF (Rho[D] Immune Globulin [Human]) with Intravascular Hemolysis in the treatment of Immune Thrombocytopenic Purpura |
01/27/2006 |
Orphan Drug Designation Granted by European Commission for Anticancer Monoclonal Antibody 1D09C3 for Chronic Lymphocytic Leukemia |
01/26/2006 |
Baxter Receives Marketing Authorization From the European Commission for Kiovig to Treat Immunodeficiencies |
01/26/2006 |
FDA Approves Sutent (sunitinib) for Gastrointestinal and Kidney Cancer |
01/26/2006 |
European Commission Approves Exubera (Inhaled Human Insulin) for Treatment of Type 1 and Type 2 Diabetes |
01/26/2006 |
BioMarin Receives FDA Fast Track Designation for Phenoptin (Sapropterin Dihydrochloride) for Phenylketonuria |
01/26/2006 |
FDA Grants Discovery Labs' Surfaxin Fast Track Designation for Prevention and Treatment of Bronchopulmonary Dysplasia |
01/25/2006 |
FDA Clarifies Status of YAZ Premenstrual Dysphoric Disorder Application |
01/24/2006 |
Pfizer's Somavert Available for Treatment of Acromegaly |
01/24/2006 |
Serono's Gonal-f Approved in Japan for the Treatment of Male Hypogonadotropic Hypogonadism |
01/24/2006 |
FDA Joint Advisory Committee Recommends Approval of Orlistat 60 mg Capsules for Over-the-Counter Use |
01/23/2006 |
FDA Public Health Advisory: Ketek (Telithromycin) Tablets |
01/23/2006 |
Nuvelo Receives FDA Fast Track Status for Alfimeprase |
01/23/2006 |
Vion Pharmaceuticals Receives Orphan Drug Designation for Cloretazine (VNP40101M) in Europe for Treatment of Acute Myeloid Leukemia |
01/19/2006 |
FDA Approves Updated Labeling with Boxed Warning and Medication Guide for Two Eczema Drugs, Elidel and Protopic |
01/18/2006 |
FDA Announces New Prescription Drug Information Format to Improve Patient Safety |
01/18/2006 |
Letter Warns of Hepatitis B Reactivation Associated with Anti-TNF alpha Products |
01/18/2006 |
FDA Grants Priority Review to Plavix (Clopidogrel Bisulfate) Supplemental New Drug Application for Additional Type of Heart Attack |
01/17/2006 |
Biovail Receives Approval for Wellbutrin XL to Treat Depression in Canada |
01/17/2006 |
BioCryst Receives FDA Fast Track Designation for Peramivir |
01/13/2006 |
FDA Warns Consumers about Brazilian Diet Pills Found to Contain Active Drug Ingredients |
01/13/2006 |
Draxis Receives FDA Approval for Diagnostic Iodine I-131 Capsules |
01/13/2006 |
Cipher receives FDA approval for Lipofen (CIP-Fenofibrate) |
01/12/2006 |
Favrille Receives FDA Fast Track Designation for FavId, Lead Product Candidate for Follicular B-Cell Non-Hodgkin's Lymphoma |
01/11/2006 |
Israeli Ministry of Health Approves Intravenous Dosing of Remodulin(R) to Treat Pulmonary Arterial Hypertension |
01/10/2006 |
FDA Approves Taclonex (Calcipotriene/Betamethasone Dipropionate), Once Daily Therapy for Treatment of Psoriasis |
01/10/2006 |
FDA Approves First Immune Globulin for Subcutaneous Use |
01/09/2006 |
FDA Approves First IV Treatment for Postmenopausal Osteoporosis, Boniva (Ibandronate Sodium) Injection |
01/06/2006 |
Drug Warning on Rho(D) Intravenous Human Immune Globulin (WinRho SDF) |
01/04/2006 |
FDA Clears Xoft's Axxent Electronic Brachytherapy System for Treatment of Breast Cancer |
01/04/2006 |
FDA Approves Once-a-Week Osteoporosis Hormone Therapy Patch Climara Pro (Estradiol/Levonorgestrel) |
01/03/2006 |
Genmab's Humax-EGFr Awarded Fast Track Status from FDA |
01/03/2006 |
Aspreva and Roche Receive Orphan Drug Designation from FDA for Evaluation of CellCept (Mycophenolate Mofetil) in Myasthenia Gravis |
12/30/2005 |
FDA Approves Astellas' Vaprisol for Treatment of Euvolemic Hyponatremia |
12/29/2005 |
U.S. FDA Approves Orencia (Abatacept) for Treatment Of Rheumatoid Arthritis |
12/29/2005 |
Femara(R) Receives US Approval as Initial Therapy for Postmenopausal Women With Early Breast Cancer After Surgery |
12/29/2005 |
Bristol-Myers Squibb Submits New Drug Application for Dasatinib |
12/28/2005 |
FDA Approves New Treatment for Myelodysplastic Syndrome |
12/28/2005 |
New Drug Application for Investigational HIV Protease Inhibitor TMC114 Submitted to US Food & Drug Administration |
12/28/2005 |
New Drug Approved for Blood Disorder Also Demonstrates Positive Results in Myeloma Clinical Trials |
12/28/2005 |
FDA Grants REVLIMID(R) NDA Approval |
12/23/2005 |
STAAR Surgical's VISIAN ICL(TM) Receives FDA Approval |
12/23/2005 |
An Association Between Avandia® and Avandamet® and Vision Problems in Diabetics |
12/22/2005 |
U.S. Food and Drug Administration Extends Prophylaxis Indication for Tamiflu(R) to Children Ages 1 to 12 |
12/22/2005 |
Schering-Plough Announces PEG-Intron and Rebetol Approved in Japan for Expanded Use in Treating Chronic Hepatitis C |
12/21/2005 |
Association of Tequin(Gatifloxacin) With Serious Hypoglycemia And Hyperglycemia |
12/20/2005 |
FDA Approves Nexavar (Sorafenib) for Treatment of Patients with Advanced Kidney Cancer |
12/19/2005 |
FDA Issues Public Health Advisory on use of NeutroSpec (Technetium [99m TC] Fanolesomab), Imaging Agent for Diagnosis of Appendicitis |
12/16/2005 |
FDA Rules Anthrax Vaccine Safe and Effective to Prevent Anthrax Regardless of Route of Exposure |
12/16/2005 |
FDA Notifies Health Care Professionals of Problem with Baxter Healthcare's Meridian Hemodialysis Instrument Kinks in Device Tubing Can Pose Serious Risk to Patients |
12/16/2005 |
Health Canada Prohibits Sale of Bextra in Canada |
12/13/2005 |
FDA Approves Insmed's Orphan Drug, Iplex (mecasermin rinfabate [rDNA origin] injection), for Treatment of Severe Primary IGF-1 Deficiency |
12/13/2005 |
Alcon Receives Approval of Retaane Suspension (Anecortave Acetate Suspension) in Australia |
12/12/2005 |
Cethrin Receives Orphan Drug Status |
12/12/2005 |
Association of Severe Mucocutaneous Reactions with the Zevalin Therapeutic Regimen |
12/12/2005 |
FDA issues an Alert and Patient and Healthcare Professional Sheets for Clarithromycin (Biaxin) |
12/09/2005 |
FDA Advising of Risk of Birth Defects with Paxil |
12/08/2005 |
Femara (Letrozole) Approved for Early Invasive Breast Cancer Post-Surgery |
12/07/2005 |
Abbott's Depakote ER (Divalproex Sodium Extended-Release Tablets) Approved for Acute Manic or Mixed Episodes Associated With Bipolar Disorder |
12/06/2005 |
FDA Warns Consumers about Unapproved and Bacterially-Contaminated Miracle II Neutralizer and Miracle II Neutralizer Gel Drug Products |
12/06/2005 |
Health Canada Approves Lipitor (Atorvastatin Calcium) to Reduce Risk of Heart Attack and Stroke for People with Diabetes |
12/05/2005 |
Approval Marks the First Recombinant Human Hyaluronidase Approved for Use as an Adjuvant Drug to Increase the Absorption and Dispersion of Other Injected Drugs |
12/05/2005 |
Reports of Serious and Life-threatening Cardiopulmonary Events with Imaging Agent NeutroSpec (Technetium [99m Tc] fanolesomab) |
12/02/2005 |
Amgen Updates Product Prescribing Information for Aranesp (darbepoetin alfa) |
12/02/2005 |
Novo Nordisk Changes Labeling for NovoSeven Coagulation Factor VIIa (Recombinant) |
12/01/2005 |
FDA Sends Out Alert about Alemtuzumab (Campath) |
11/30/2005 |
Zydena (Udenafil), a New Erectile Dysfunction (ED) Drug, Receives Marketing Approval in Korea |
11/30/2005 |
FDA Approves New Indication for Avelox (moxifloxacin HCl) for Treatment of Complicated Intra-Abdominal Infections |
11/28/2005 |
Contraindication of Femara (Letrozole) in Premenopausal Women |
11/28/2005 |
POZEN Receives Approval for MT 100 in the United Kingdom |
11/28/2005 |
Solvay Pharmaceuticals Completes Market Authorization in 28 European Countries for Duodopa, its Treatment for Advanced Parkinson's Disease |
11/24/2005 |
Effexor XR Approved in Canada for Symptomatic Relief of Panic Disorder |
11/24/2005 |
FDA Issues Approvable Letter in Response to Application for Use of Fuzeon® with Needle-Free Injection Device |
11/23/2005 |
Xyrem (Sodium Oxybate) Receives FDA Approval for the Treatment of Excessive Daytime Sleepiness in Patients with Narcolepsy |
11/21/2005 |
Effexor XR (venlafaxine HCl) Approved for Treatment of Panic Disorder |
11/18/2005 |
FDA Has Public Health Advisory on Inhaled Long-acting Bronchodilator Drugs |
11/17/2005 |
First Oncolytic Viral Therapy Approved for Head and Neck Cancer |
11/17/2005 |
Labopharm's Once-Daily Tramadol Product Launched in Germany |
11/16/2005 |
Procoralan (Ivabradine), the First Pure Heart Rate-Lowering Agent, Receives Marketing Authorization in Europe |
11/15/2005 |
MediGene's Drug Eligard Launched in Spain and Further European Countries |
11/14/2005 |
Bronchitol Granted Orphan Drug Status in Europe |
11/14/2005 |
Ferring Pharmaceuticals Announces Launch of Euflexxa for Osteoarthritis Knee Pain |
11/14/2005 |
FDA Approves New Indication for Invanz (Ertapenem) for Treatment of Moderate to Severe Complicated Foot Infection in Diabetic Patients without Osteomyelitis |
11/11/2005 |
Solbec's Coramsine Receives Orphan Drug Designation from the FDA |
11/11/2005 |
FDA Updates Labeling for Ortho Evra Contraceptive Patch |
11/10/2005 |
New Safety Information for Amevive (alefacept) |
11/10/2005 |
NeoRx Announces Orphan Drug Designation for Picoplatin for Treatment of Small Cell Lung Cancer |
11/09/2005 |
UCB Receives FDA Orphan Drug Designation for Brivaracetam for the Treatment of Symptomatic Myoclonus |
11/08/2005 |
FDA Approves IND for SPC2996 in Chronic Lymphocytic Leukaemia |
11/07/2005 |
Insulin Initiation With NovoMix 30 (Biphasic Insulin Aspart) Yields Significantly Greater Blood Glucose Reductions than Basal Insulin |
11/07/2005 |
Xolair (omalizumab) - First in Class Treatment Launched in UK for Severe, Uncontrolled Asthma |
11/04/2005 |
Pfizer's Revatio (Sildenafil Citrate) Receives European Approval to Treat Pulmonary Arterial Hypertension |
11/03/2005 |
New Preservative-Free Glaucoma Treatment Cosopt (dorzolamide hydrochloride/timolol maleate) Now Available in Canada |
11/03/2005 |
Exjade, a Breakthrough Once-Daily Oral Iron Chelator, Receives First Approval Worldwide in the U.S. |
11/03/2005 |
FDA Approves Tarceva in Combination with Gemcitabine Chemotherapy for Treatment of Locally Advanced, Inoperable or Metastatic Pancreatic Cancer |
11/01/2005 |
ACTOplus met (pioglitazone HCl and metformin HCl) Now Available in U.S. Pharmacies |
10/31/2005 |
Pfizer's Zeldox Receives Approval in Europe to Treat Manic or Mixed Episodes Associated With Bipolar Disorder |
10/31/2005 |
New Targeted Biological Treatment Available for Canadian Psoriasis Patients |
10/31/2005 |
Abbott Receives FDA Approval for New Kaletra (Lopinavir/Ritonavir) Tablet Formulation for HIV Patients |
10/28/2005 |
Galderma Receives FDA Approval for Clobex (Clobetasol Propionate) Spray for Moderate-to-Severe Plaque Psoriasis |
10/28/2005 |
GlaxoSmithKline Announces Approval of Arranon (nelarabine) Injection |
10/28/2005 |
European Commission Approves Kepivance (Palifermin) for Oral Mucositis in Cancer Patients Undergoing Blood and Bone Marrow Transplant |
10/27/2005 |
Treatment Option Approved by FDA Now Available to Treat Anxiety Disorders |
10/27/2005 |
Noxafil (Posaconazole) Oral Suspension Approved in European Union for Treatment of Invasive Fungal Infections |
10/27/2005 |
Xolair Granted Marketing Authorization in Europe as Treatment for Severe Allergic Asthma |
10/26/2005 |
EU Commission Approves Aptivus (Tipranavir) for Treatment of HIV |
10/25/2005 |
FDA Grants Priority Review for Rituxan (Rituximab) Supplemental Biologics License Application for Front-Line Treatment of Intermediate-Grade or Aggressive Non-Hodgkin's Lymphoma |
10/21/2005 |
Cephalon Receives Approvable Letter for Sparlon for Treatment of ADHD in Children and Adolescents |
10/21/2005 |
Bayer Wins Approval for Avelox (Moxifloxacin) in Japan |
10/20/2005 |
FDA Approves Levemir (Insulin Detemir [rDNA Origin] Injection) for Treatment of Diabetes in Children |
10/18/2005 |
GlaxoSmithKline's Havrix (hepatitis A vaccine, inactivated) Now Approved For Use in Children Aged 12 Months and Older |
10/18/2005 |
ALK-Abelló Announces Positive Results from New Grass Tablet Study |
10/17/2005 |
FDA Approves Baxter's Flexbumin, the First and Only Albumin Solution to Be Packaged in a Flexible Container |
10/17/2005 |
Ebixa, Extended Approval for Treatment of Moderate Alzheimer's Disease |
10/13/2005 |
Exubera (Insulin Human) Receives Positive Opinion from CHMP for Treatment of Type 1 and Type 2 Diabetes |
10/11/2005 |
Novo Nordisk Receives EU Approval of NovoMix 50 and NovoMix 70 Premixed Insulin Analogues |
10/10/2005 |
FDA Approves Room Temperature Storage of ZLB Behring's Helixate FS |
10/06/2005 |
Bayer Receives FDA Approval for Room Temperature Storage of Kogenate FS (Antihemophilic Factor (Recombinant) |
10/06/2005 |
Remicade (Infliximab) Receives Approval in European Union for Treatment of Moderate to Severe Plaque Psoriasis |
10/05/2005 |
FDA Approves Pfizer's Aromasin (Exemestane Tablets) for Adjuvant Treatment of Early Breast Cancer in Postmenopausal Women |
10/05/2005 |
Follistim AQ Vial Now Available in 75 IU and 150 IU Presentations |
10/05/2005 |
Shorter Course of Peg-Intron and Rebetol Combination Therapy Approved in European Union for Certain Hepatitis C Patients With Genotype 1 and Low Viral Load |
10/05/2005 |
Schering AG Receives EU Approval for Novel Contrast Agent Vasovist |
10/04/2005 |
Humira (Adalimumab) Receives FDA Approval for Treatment of Psoriatic Arthritis Patients on Humira Showed Substantial Improvement in Skin and Joint Symptoms of the Disease |
10/04/2005 |
Xechem's Orphan Drug Status Approved for Its Sickle Cell Medicine in the European Union |
10/04/2005 |
Humira (adalimumab) Receives FDA Approval for First-Line Treatment of Moderate to Severe Rheumatoid Arthritis |
10/04/2005 |
Data and Safety Monitoring Board Recommends Discontinuation of Canvaxin Phase 3 Clinical Trial for Patients with Stage III Melanoma |
10/03/2005 |
Sanofi Pasteur Notifies Health Care Providers of Need to Report Adverse Events Following Administration of Menactra(R) Meningococcal Vaccine |
09/30/2005 |
FDA Issues Public Health Advisory on Strattera (Atomoxetine) for Attention Deficit Disorder |
09/30/2005 |
FDA Advisory Committee Votes Unanimously to Recommend Approval of Exjade(R) for Once-Daily Oral Treatment of Chronic Iron Overload Due to Blood Transfusions |
09/29/2005 |
FDA Approves Angeliq (Drospirenone/Estradiol) to Treat Menopausal Symptoms |
09/29/2005 |
Critical Therapeutics Announces FDA Approval of Zyflo (Zileuton Tablets) for the Prevention and Chronic Treatment of Asthma |
09/28/2005 |
Allergan Receives Positive Opinions for Combigan(TM) from 21 Countries in European Union |
09/28/2005 |
Insmed Receives Approvable Letter for iPlex (rhIGF-I/rhIGFBP-3) |
09/27/2005 |
EMEA Grants Orphan Drug Designation to Troxatyl (Troxacitabine) for Treatment of Acute Myeloid Leukemia |
09/27/2005 |
FDA Approves Pfizer's Lipitor (atorvastatin calcium) to Reduce Risk of Strokes and Heart Attacks in Patients With Diabetes |
09/26/2005 |
Baxter Announces the U.S. Launch of GammaGard Liquid 10% for Patients With Primary Immunodeficiency Disorders |
09/26/2005 |
FDA Accepts Altace Supplemental New Drug Application for Delaying the Progression of Chronic Kidney Disease in Hypertensive, Non-Diabetic Patients |
09/23/2005 |
European Commission Approves Use of Anti-Epileptic Keppra as Adjunctive Therapy in Children Four Years of Age and Older with Partial-Onset Seizures |
09/23/2005 |
Cipralex Approved for the Treatment of Generalised Anxiety Disorder in the EU |
09/21/2005 |
PrDiovan (valsartan) Approved to Reduce Cardiovascular Death in Those at High Risk |
09/21/2005 |
Tarceva Approved in Europe for Lung Cancer |
09/20/2005 |
Arimidex (Anastrozole) Gains Full FDA Approval for Adjuvant Treatment of Hormone Receptor-Positive Early Breast Cancer in Postmenopausal Women |
09/19/2005 |
Once-Monthly Oral Bonviva Approved for Postmenopausal Osteoporosis in Europe |
09/16/2005 |
FDA Approves Remicade (infliximab) as First and Only Biologic to Treat Ulcerative Colitis |
09/16/2005 |
BioMarin Announces Positive Opinion for Naglazyme (Galsulfase) From European Regulatory Authority |
09/16/2005 |
FDA Approves NovoLog (Insulin Aspart [rDNA Origin] Injection) for Treatment of Diabetes in Children |
09/16/2005 |
FDA Expands Neulasta (Pegfilgrastim) Label, Extends First-Cycle Protection From Infection to Cancer Patients Receiving Moderately Myelosuppressive Chemotherapy |
09/16/2005 |
Macugen (Pegaptanib Sodium Injection) Receives Positive Opinion From Europe's CHMP for Treatment of Wet Age-Related Macular Degeneration |
09/15/2005 |
FDA Advisory Committee Recommends Accelerated Approval of GlaxoSmithKline's Arranon (nelarabine) Injection |
09/15/2005 |
New Treatment Option for Second Leading Cause of Cancer Deaths in Canada, Health Canada Approves Erbitux (Cetuximab) for the Treatment of Metastatic Colorectal Cancer |
09/15/2005 |
Alkermes Announces Risperdal Consta Approved in Italy |
09/14/2005 |
FDA Oncologic Drugs Advisory Committee Recommends Revlimid for Full Approval |
09/14/2005 |
Cephalon Receives FDA Approval to Market Sugar-Free Formulation of Actiq |
09/14/2005 |
Pfizer Receives European Approval to Market Aromasin(R) for Adjuvant Treatment of Early Breast Cancer in Postmenopausal Women |
09/13/2005 |
FDA Approves ParaGard IUD for Women Who Have Not Yet Had Children |
09/12/2005 |
Health Canada Approves Groundbreaking Cancer Treatment Avastin (Bevacizumab, rhuMAb-VEGF) for Colorectal Cancer |
09/09/2005 |
FDA Advisory Committee Recommends Approval of Exubera (insulin [rDNA origin] powder for oral inhalation) for Use in Adults With Type 1 and 2 Diabetes |
09/09/2005 |
Biovail's Tramadol ER Receives FDA Approval |
09/09/2005 |
Once-Monthly Oral Bonviva Approved for Postmenopausal Osteoporosis in Switzerland |
09/06/2005 |
Labopharm Receives Regulatory Approval of Once-Daily Pain Product, Tramadol, for 22 European Countries |
09/06/2005 |
Ambien CR (Zolpidem Tartrate Extended-Release Tablets) CIV Receives FDA Approval for the Treatment of Insomnia |
08/31/2005 |
Health Canada Approves New Targeted Radioimmunotherapy |
08/31/2005 |
GlaxoSmithKline Announces FDA Approval of Fluarix(TM) (Influenza Virus Vaccine) |
08/31/2005 |
FDA Grants Expanded Label for Ventavis (Iloprost) Inhalation Solution |
08/31/2005 |
Cephalon Receives Approval to Market Modafinil for Shift Work Sleep Disorder in Germany |
08/31/2005 |
FDA Approves Tercica's Increlex for Short Stature Caused by Severe Primary IGF-1 Deficiency |
08/30/2005 |
ACTOplus Met Approved by the FDA for Type 2 Diabetes |
08/25/2005 |
FDA Clears Masimo SET LNOP Blue(TM) Sensor, the First and Only Pulse Oximeter Sensor to Accurately Monitor Cyanotic Babies |
08/25/2005 |
KV Pharmaceutical Announces First Asian Approval for Gynazole-1 |
08/24/2005 |
FDA Approves Aceon to Reduce Risk of Cardiovascular Mortality or Non-Fatal MI in Patients With Stable Coronary Artery Disease |
08/19/2005 |
New Formulation of Allergan's Alphagan P Receives U.S. FDA Approval |
08/19/2005 |
Oral Solution Formulation of Namenda (Memantine HCl), the Only FDA-Approved Oral Solution for Moderate to Severe Alzheimer's Disease, Now Available |
08/18/2005 |
First Single-Dose Oral Antibiotic Zmax (Azithromycin Extended Release) Available in US Pharmacies for Adults with Certain Types of Sinusitis and Pneumonia |
08/18/2005 |
Ariad Receives Orphan Drug Designations for AP23573 in the Treatment of Both Soft-Tissue and Bone Sarcomas |
08/18/2005 |
Schering's New Low-Dose Oral Contraceptive Yasminelle (Ethinyl Estradiol/Drospirenone) Approved in the Netherlands |
08/15/2005 |
FDA Approves Actonel With Calcium (Risedronate Sodium With Calcium Carbonate Tablets) for Postmenopausal Osteoporosis |
08/15/2005 |
Humira (Adalimumab) Approved in Europe for Treatment of Psoriatic Arthritis and as First-Line Treatment of Severe Rheumatoid Arthritis |
08/15/2005 |
FDA Approves Fortical (calcitonin-salmon), Unigene's Nasal Calcitonin Product for Postmenopausal Osteoporosis |
08/12/2005 |
FDA Approves Isotretinoin Pregnancy Risk Management Program |
08/12/2005 |
Concerta (Methylphenidate HCl) Approved for Treatment of ADHD in Adolescents |
08/08/2005 |
FDA Approves Levaquin (Levofloxacin) for Short-Course Treatment of Acute Bacterial Sinusitis |
08/04/2005 |
FDA Approves Diovan (Valsartan) to Reduce Cardiovascular Death in Heart Attack Survivors at High Risk |
08/01/2005 |
FDA Grants Fast Track Designation for Panitumumab for Treatment of Metastatic Colorectal Cancer |
08/01/2005 |
FDA Approves New Use for Celebrex (Celecoxib), for Patients with Ankylosing Spondylitis |
08/01/2005 |
FDA Grants Orphan Drug Designation for Lysosomal Acid Lipase |
07/27/2005 |
FDA Approves S-Caine Patch (Lidocaine/Tetracaine) Topical Local Anesthetic Patch |
07/25/2005 |
FDA Approves Rozerem (Ramelteon), Non-Scheduled Prescription Sleep Medication |
07/22/2005 |
FDA Approves Onyx Liquid Embolic System for Treatment of Brain Vascular Disorder |
07/22/2005 |
FDA Expands Indication for Adderall XR (Mixed Salts of a Single-Entity Amphetamine Product) Confirming Safety and Efficacy in Adolescents |
07/22/2005 |
FDA Issues Approvable Letter for Entereg (Alvimopan), for Management of Postoperative Ileus |
07/19/2005 |
FDA Grants Fast Track Status for the Investigational HIV Protease Inhibitor 640385 (VX-385) |
07/18/2005 |
Avelox IV (Moxifloxacin) Approved in Europe to Treat Complicated Skin and Skin Structure Infections |
07/18/2005 |
Health Canada Approves Influvac, Influenza Vaccine Will Be Available for Flu Season |
07/15/2005 |
FDA Approves Re-Formulated Clarinex (desloratadine) Reditabs(R) Tablets - Orally Disintegrating Prescription Antihistamine |
07/14/2005 |
Bioniche Launches Sotradecol Injection (Sodium Tetradecyl Sulfate Injection) for Varicose Veins in U.S. |
07/14/2005 |
Tarceva (Erlotinib) Granted Approval in Canada for the Treatment of Advanced Non-Small Cell Lung Cancer |
07/13/2005 |
European Commission Approves New Use of Arixtra for Prevention of Venous Thromboembolic Events in Abdominal Surgery |
07/08/2005 |
Aczone (dapsone) Gel 5% Approved for Treatment of Acne by the FDA |
07/07/2005 |
European Medicines Agency Grants Orphan Drug Designation for PTC124 for Treatment of Duchenne Muscular Dystrophy and Cystic Fibrosis |
07/07/2005 |
FDA Approves of Metrogel (Metronidazole) Topical Gel 1% for Rosacea |
07/06/2005 |
FDA Approves Megace ES for Anorexia, Cachexia, or Unexplained, Significant Weight Loss in Patients With AIDS |
06/30/2005 |
FDA Approves New Indication for Topamax (Topiramate) as Initial Monotherapy for Adults and Children with Epilepsy |
06/30/2005 |
FDA Approves of Avelox (Moxifloxacin HCl) for Treatment of Complicated Skin and Skin Structure Infections |
06/28/2005 |
Xenical Gains European Approval for Use in Young People |
06/24/2005 |
FDA Approves UCB's Keppra (Levetiracetam) for Use in Childhood Epilepsy |
06/24/2005 |
FDA Approves Bidil for Treatment of Heart Failure in Black Patients |
06/23/2005 |
U.S. FDA Approves New Anti-HIV Drug Aptivus For Use In Combination Therapy |
06/17/2005 |
AstraZeneca Announces US Label Change for Iressa (Gefitinib) and New Distribution |
06/16/2005 |
FDA Approves First-Ever Treatment for Adults, Teens with Diarrhea Caused by Cryptosporidium Infection |
06/16/2005 |
FDA Approves Tygacil (Tigecycline), First-In-Class Antibiotic |
06/15/2005 |
FDA Approves Oral Xeloda (Capecitabine) for Adjuvant Treatment of Colon Cancer |
06/13/2005 |
Pfizer's Single-Dose Antibiotic Zmax (Azithromycin Extended Release) Receives FDA Approval |
06/13/2005 |
Novartis Receives EU Marketing Authorization for Diovan to Treat People With Heart Failure |
06/13/2005 |
FDA Approves Pfizer's Lyrica (Pregabalin) as Epilepsy Add-On Treatment for Partial Onset Seizures |
06/10/2005 |
Temodal (Temozolomide) Approved in European Union For Treatment of Newly Diagnosed Glioblastoma Multiforme |
06/09/2005 |
Byetta (Exenatide), Newly Approved First-in-Class Treatment for Type 2 Diabetes, Now Available in US |
06/08/2005 |
Actelion Launches Tracleer (Bosentan) in Pulmonary Arterial Hypertension in Japan |
06/08/2005 |
Antigenics' Oncophage Cancer Vaccine Receives European Orphan Drug Designation for Renal Cell Carcinoma |
06/08/2005 |
Virulizin(R) Granted Orphan Drug Status in European Union |
06/07/2005 |
Virulizin, Treatment For Pancreatic Cancer, Granted Orphan Drug Status in European Union |
06/07/2005 |
Oncophage (HSPPC-96) Cancer Vaccine Receives European Orphan Drug Designation for Renal Cell Carcinoma |
06/07/2005 |
Convenient New Formulation of Aricept (Donepezil) Now Available for Treatment of Mild-To-Moderate Alzheimer's Disease |
06/06/2005 |
FDA Approves Revatio (Sildenafil Citrate) As Treatment for Pulmonary Arterial Hypertension |
06/03/2005 |
FDA Approves Extended-Release Glumetza (metformin hydrochloride) for Type II Diabetes |
06/01/2005 |
Europe Grants Orphan Drug Designation to Proxinium for Treatment of Head and Neck Cancer |
06/01/2005 |
Xolair (Omalizumab), Antibody Therapy for Asthma, Available in Canada |
06/01/2005 |
FDA Expands Enbrel (Etanercept) Psoriatic Arthritis Indication |
06/01/2005 |
Health Canada Approves Glumetza (Metformin) to Treat Type II Diabetes |
06/01/2005 |
FDA Grants Orphan Drug Status to Naglazyme (galsulfase), Treatment for Mucopolysaccharidosis VI |
05/31/2005 |
Taxotere (Docetaxel) Approved by Health Canada to Treat Prostate Cancer |
05/27/2005 |
Cellegesic (Nitroglycerin Ointment) Launched in the United Kingdom |
05/27/2005 |
FDA Approves Zemplar (Paricalcitol) Capsules For Earlier Treatment Of Kidney Disease Complication |
05/27/2005 |
Europe Approves Invirase (Saquinavir Mesylate) 500 mg Tablet for the Treatment of HIV |
05/27/2005 |
European Agency Issues Positive Opinion for Use of Arixtra (Fondaparinux) in Prevention of Venous Thromboembolic Events in Abdominal Surgery |
05/27/2005 |
FDA Grants Approval for Focalin XR (Dexmethylphenidate) for Treatment of Attention-Deficit Hyperactivity Disorder in Adults, Adolescents and Children |
05/25/2005 |
FDA Issues Approvable Letter for Retaane Suspension (Anecortave) for treatment of Wet Age-Related Macular Degeneration |
05/24/2005 |
FDA Approves Updated Labeling for Coreg (Carvedilol) Showing Benefits for Heart Attack Patients With Damaged Hearts and Heart Failure Patients |
05/24/2005 |
Brazil Approves Macugen (Pegaptanib Sodium Injection) in Brazil for the Treatment of Neovascular (Wet) Age-Related Macular Degeneration |
05/20/2005 |
Depomed Receives FDA Approval of Proquin XR for Uncomplicated Urinary Tract Infections |
05/19/2005 |
FDA Approves Atacand (Candesartan Cilexetil) For Use With An Ace Inhibitor In The Treatment Of Heart Failure |
05/18/2005 |
Certican (Everolimus) Approved by Swissmedic to Reduce Risk of Organ Rejection in Heart and Kidney Transplant Patients |
05/17/2005 |
Trizivir (Abacavir Sulfate, Lamivudine, and Zidovudine) Receives Traditional Approval Status From FDA |
05/17/2005 |
FDA Approves Remicade (Infliximab) for Psoriatic Arthritis |
05/16/2005 |
FDA Approves Pegasys (Peginterferon alfa-2a) as Pegylated Interferon for the Treatment of Chronic Hepatitis B |
05/14/2005 |
FDA Grants Access to Sorafenib (BAY 43-9006) for Individuals With Advanced Renal Cell Carcinoma |
05/13/2005 |
Anti-Fungal Agent Mycamine (Micafungin Sodium) Available to Physicians in US |
05/12/2005 |
FDA Grants Orphan Drug Designation for Troxatyl (Troxacitabine) |
05/12/2005 |
FDA Grants Orphan Drug Status to PulmoLAR, Treatment for Pulmonary Arterial Hypertension |
05/10/2005 |
Diovan Receives European Union Approval for Treatment of Heart Attack Survivors |
05/09/2005 |
FDA Approves Triglide, A Novel Formulation Of Fenofibrate, for Treatment of Lipid Disorders |
05/06/2005 |
FDA Issues Approval Letter For Tramadol ODT, for Moderate to Severe Pain |
05/06/2005 |
Health Canada Approves Macugen (Pegaptanib Sodium Injection) Treatment of Neovascular (Wet) Age Related Macular Degeneration |
05/05/2005 |
FDA Approves Requip (Ropinirole HCl) for Treatment of Moderate-to-Severe Primary Restless Legs Syndrome in Adults |
05/03/2005 |
FDA Approves Boostrix® Vaccine for Adolescents Against Pertussis |
05/02/2005 |
FDA Approves Baxter's Gammagard Liquid 10% for Patients With Primary Immunodeficiency Disorders |
05/02/2005 |
FDA Approves Once-Daily Kaletra-Based (Lopinavir/Ritonavir) Treatment Regimen |
04/29/2005 |
FDA Approves of Byetta (Exenatide) Injection, Treatment for Type 2 Diabetes |
04/25/2005 |
5-Day Antibiotic Treatment For Acute Sinusitis: Presented at Health Canada Approves New Indication for Ketek (Telithromycin) |
04/25/2005 |
Multiferon (Natural Human Alpha Interferon) Approved for Sale in the Philippines |
04/21/2005 |
Europe Grants Marketing Authorization for Aclasta (Zoledronic Acid for Infusion), Treatment for Paget's Disease |
04/20/2005 |
Health Canada Allows "Morning After Pill", Plan B (Levonorgestrel) To Be Available Without Prescription |
04/19/2005 |
Equetro (Carbamazepine Extended-Release) Now Available in US for Treatment of Manic and Mixed Episodes in Bipolar Disorder |
04/19/2005 |
FDA Public Health Advisory About Elidel (Pimecrolimus) Cream and Protopic (Tacrolimus) Ointment |
04/14/2005 |
FDA Approves Hyzaar (Losartan Potassium-Hydrochlorothiazide) Fixed-Dose Combination |
04/14/2005 |
FDA Grants Orphan Drug Status for Panzem (2ME2), Treatment for Ovarian Cancer |
04/13/2005 |
FDA Issues Public Health Advisory for Antipsychotic Drugs used for Treatment of Behavioral Disorders in Elderly Patients |
04/11/2005 |
FDA Approves Orphan Drug Retisert (Fluocinolone Acetonide Intravitreal Implant), for Treatment of Chronic Non-Infectious Uveitis |
04/11/2005 |
FDA Approves Liquid Formulation of WinRho SDF for Treatment of Immune Thrombocytopenic Purpura |
04/11/2005 |
FDA Issues Approvable Letter for Ambien CR (Zolpidem Tartrate Extended Release) CIV for the Treatment of Insomnia |
04/11/2005 |
Health Canada Approves Femara (Letrozole), Treatment Option to Improve Disease-Free Survival Beyond Five Years of Breast Cancer Diagnosis |
04/08/2005 |
FDA Approves Fosamax Plus D (Alendronate Sodium/Cholecalciferol With Vitamin D) to Reduce Risk of Hip and Spine Fractures |
04/07/2005 |
New FDA Labeling for Pfizer's Celebrex, Pfizer Agrees to Suspend Sales of Bextra |
04/07/2005 |
Lunesta Now Widely Available by Prescription to Treat Insomnia Estimated 100 Million Americans Suffer from Insomnia |
04/04/2005 |
Novo Nordisk Receives EU Approval for Broader Use of Levemir and NovoRapid |
04/04/2005 |
Helsinn's New Antiemetic Drug Aloxi Receives Marketing Authorization in Europe |
04/01/2005 |
FDA Approves Intravenous Formulation for Nexium (Esomeprazole Magnesium) for GERD |
04/01/2005 |
Xeloda (Capecitabine) Granted European Union Approval for Adjuvant Therapy in the Treatment of Colon Cancer |
03/31/2005 |
FDA Approves Asmanex (mometasone furoate) for Once Daily Management of Asthma |
03/30/2005 |
Health Canada Approves New Indication for Fragmin (Dalteparin Sodium), for Reduction of Cancer-Associated Thrombosis |
03/30/2005 |
FDA Approves Baraclude (Entecavir) for Treatment of Chronic Hepatitis B |
03/29/2005 |
FDA Approves Zofran (Ondansetron) For Use in Children as Young as One Month of Age |
03/29/2005 |
FDA Approves Depo-subQ Provera 104 (Medroxyprogesterone) for Management of Endometriosis Pain |
03/28/2005 |
FDA Approves Once-Monthly Boniva (Ibandronate Sodium) for Osteoporosis |
03/28/2005 |
FDA Grants Full Approval for Velcade (Bortezomib) for Injection; Claims Include Survival Advantage and Use in Second-Line Multiple Myeloma |
03/28/2005 |
ISTA Pharmaceuticals Receives FDA Approval for Xibrom for the Treatment of Ocular Inflammation Following Cataract Surgery |
03/25/2005 |
FDA Issues Approvable Letter for Sugar-Free Formulation of Actiq (Oral Transmucosal Fentanyl Citrate) |
03/23/2005 |
Colombian Food and Drug Agency Approves Impavido (Miltefosine) for Parasitic Skin Disease |
03/22/2005 |
Treatment for Locally Advanced or Metastatic Lung Cancer, Tarceva (Erlotinib), Granted First European Approval in Switzerland |
03/22/2005 |
Ventavis (Iloprost) Now Commercially Available for the Treatment of Pulmonary Arterial Hypertension |
03/21/2005 |
FDA Approves New Drug, Symlin (Pramlintide Acetate), to Treat Type 1 and Type 2 Diabetes |
03/18/2005 |
FDA Advisory Panel Recommends Licensure of Adacel Vaccine for Combined Protection against Tetanus, Diphtheria and Pertussis |
03/18/2005 |
European Commission Grants Marketing Authorization for anti-epileptic Zonegran (Zonisamide) |
03/17/2005 |
FDA Approves Antifungal Mycamine (Micafungin Sodium) |
03/17/2005 |
Taxol (Paclitaxel) Approved in Europe for the Adjuvant Treatment of Node-Positive Breast Cancer |
03/17/2005 |
Abilify (Aripiprazole) Granted Approval for New Indication, Bipolar I Disorder |
03/16/2005 |
FDA Approves Temodar (Temozolomide) as Treatment for Patients With Newly Diagnosed Glioblastoma Multiforme |
03/14/2005 |
FDA Approves Xopenex HFA (Levalbuterol Tartrate) Metered-Dose Inhaler |
03/14/2005 |
Avastin (Bevacizumab, rhuMAb-VEGF), Treatment for Advanced Colorectal Cancer, Launching in Europe |
03/14/2005 |
Public Advisory - Health Canada Endorsed Important Safety Information on Crestor (Rosuvastatin) |
03/08/2005 |
Canada Expands Approval of Cancidas (Caspfungin Acetate) for Empirical Treatment of Fungal Infections in Febrile-Neutropenic Patients |
03/08/2005 |
France Approves Use of Remodulin (Treprostinil Sodium) for Primary Pulmonary Hypertension |
03/07/2005 |
Femara Approved in Germany as the Only Hormonal Therapy Given After Standard Tamoxifen for Post-menopausal Woman with Early Breast Cancer |
03/07/2005 |
Abilify (Aripiprazole) Granted Approval for New Indication, Bipolar I Disorder |
03/04/2005 |
FDA Approves Clarinex-D 24 Hour Prescription-Strength Once-Daily Nondrowsy Antihistamine with a Decongestant |
03/03/2005 |
Europe Approves Thyrogen (Thyrotropin Alfa) for Use in Thyroid Cancer Ablation |
02/28/2005 |
Canasa (Mesalamine) Suppository for Treatment of Ulcerative Proctitis Launched in US |
02/28/2005 |
FDA Approves First Ever Treatment for Hepatitis C in Patients with HIV |
02/23/2005 |
FDA Approves Atacand (Candesartan Cilexetil) for the Treatment of Heart Failure |
02/22/2005 |
FDA Grants Fast Track Designation for Aerosolized Amikacin |
02/18/2005 |
EU Scientific Committee Recommends Approval of Cymbalta (Duloxetine) For Treatment of Diabetic Peripheral Neuropathic Pain |
02/18/2005 |
Orphan Drug Status Granted for Once-Daily Tramadol for Treatment of HIV-Associated Neuropathy |
02/18/2005 |
FDA Grants Priority Review to Keppra (Levetiracetam) for Use in Childhood Epilepsy |
02/14/2005 |
New Opiate Addiction Treatment, Subutex (Buprenorphine Hydrochloride), Approved by Health Canada |
02/10/2005 |
Health Canada Approves Pediatric Indication for Prevacid (Lansoprazole) for Children with Gastroesophageal Reflux Disease |
02/10/2005 |
Health Canada Requests Suspension of Sales of Adderall XR |
02/08/2005 |
Health Canada Endorses Important Safety Information on Ezetrol (Ezetimibe) |
02/07/2005 |
FDA Grants Full Approval to Doxil (Doxorubicin), Treatment for Progression or Recurrence of Ovarian Cancer |
02/07/2005 |
Ozone Friendly Formulation, Flovent HFA (Fluticasone Propionate HFA) Inhalation Aerosol, Now Available in US |
02/04/2005 |
FDA Approves New Eloxatin (Oxaliplatin) Formulation |
02/04/2005 |
FDA Grants Orphan Drug Designation for Proxinium, Treatment for Advanced, Recurrent Head and Neck Cancer |
01/31/2005 |
New Treatment Guidelines Recommend Valcyte (Valganciclovir) for AIDS-Related Cytomegalovirus Retinitis |
01/26/2005 |
Norditropin NordiFlex (somatropin [rDNA] injection), Treatment for Growth Hormone Deficiency, Now Available in US |
01/25/2005 |
Japan Approves Enbrel (Etanercept) for Treatment of Rheumatoid Arthritis |
01/25/2005 |
Abraxane (Paclitaxel) for Injectable Suspension, Treatment for Metastatic Breast Cancer, Available in US in Early February |
01/21/2005 |
Eyetech Announces Launch Date for Macugen (Pegaptanib Sodium Injection) |
01/19/2005 |
Immunomedics Announces Canadian Approval of LeukoScan |
01/19/2005 |
Vesicare (Solifenacin Succinate) Now Available in the United States |
01/17/2005 |
Warner Chilcott Announces Approval of Low-Dose femhrt® 0.5 mg/2.5 mcg |
01/14/2005 |
European Commission Approves Avastin (Bevacizumab, rhuMAb-VEGF), Treatment for Metastatic Colorectal Cancer |
01/12/2005 |
Oral Contraceptive Yasmin (Drospirenone/Ethinyl Estradiol) Approved in Canada |
01/12/2005 |
Scent-Free Formulation of Nasonex (Mometasone Furoate Monohydrate) Launched in US |
01/11/2005 |
First New Treatment for Alcoholism in Ten Years, Now Available Campral (Acamprosate Calcium) Delayed-Release Tablets |
01/10/2005 |
FDA Approves Abraxane (paclitaxel) for Treatment of Metastatic Breast Cancer |
01/07/2005 |
FDA Issues Approvable Letter for Bonefos (Clodronate) for Adjuvant Treatment of Breast Cancer |
01/06/2005 |
Strattera (Atomoxetine), Non-Stimulant Medication For Attention-Deficit/Hyperactivity Disorder, Now Approved In Canada |
01/06/2005 |
Health Canada Approves New Cream Treatment, Aldara (Imiquimod) for Basal Cell Carcinoma |
01/06/2005 |
Vitrase (Hyaluronidase Injection) Now Available to US Ophthalmologists |
01/05/2005 |
FDA Grants "Fast Track" Status for ACAM2000 Smallpox Vaccine |
01/03/2005 |
FDA Approves Expanded Indication for Bexxar (Tositumomab) in Non-Hodgkin's Lymphoma |
01/03/2005 |
FDA Approves Lyrica (Pregabalin) for Treatment of Neuropathic Pain |
12/29/2004 |
FDA Approves Ventavis (Iloprost) for Treatment of Pulmonary Arterial Hypertension |
12/29/2004 |
FDA Approves Antifungal VFEND (Voriconazole) for Treatment of Serious Bloodstream Infections Caused by Candida in Nonneutropenic Patients |
12/29/2004 |
FDA Approves Prialt (Ziconotide Intrathecal Infusion) for Severe Chronic Pain |
12/23/2004 |
FDA Approves Enablex (Darifenacin) for Treatment of Overactive Bladder |
12/21/2004 |
FDA Approves Enjuvia (Synthetic Conjugated Estrogens, B) 0.3 and 0.45 Mg Tablets |
12/21/2004 |
FDA Approves Remicade (Infliximab) for Patients with Ankylosing Spondylitis, Label Also Updated |
12/20/2004 |
FDA Approves New 500 mg Tablet Formulation of Invirase (Saquinavir Mesylate) |
12/20/2004 |
FDA Approves Macugen (Pegaptanib Sodium) for Treatment of Neovascular (Wet) Age-Related Macular Degeneration |
12/16/2004 |
FDA Grants Remicade (Infliximab) Fast Track Designation For Treatment Of Active Ulcerative Colitis |
12/16/2004 |
FDA Approves Kepivance (Palifermin) for Severe Oral Mucositis in Cancer Patients Undergoing Bone Marrow Transplant |
12/16/2004 |
FDA Approves Nasonex (Mometasone ) for Treatment of Nasal Polyps |
12/16/2004 |
FDA Approves Lunesta (Eszopiclone), Formerly Estorra, for Treatment of Insomnia |
12/15/2004 |
FDA Approves Bausch & Lomb's Zylet Ophthalmic Combination Rx Drug |
12/15/2004 |
FDA Approves Eligard (Leuprolide Acetate) 6-Month Formulation For Prostate Cancer |
12/13/2004 |
FDA Approves Equetro (Extended-Release Carbamazepine) for Bipolar Disorder |
12/08/2004 |
FDA Grants Orphan Drug Designation for PTC124 for Treatment of Cystic Fibrosis |