US FDA Panel Rejects Jazz Pharmaceuticals, Inc. (JAZZ) Drug For Fibromyalgia; Stock Falls at Market Close
8/24/2010
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FDA Panel Backs Wider Use Of Eli Lilly and Company (LLY)'s Cymbalta
8/23/2010
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FDA Approves HRA Pharma, Watson Pharmaceuticals, Inc. (WPI)'s "Morning-After" Pill Ella
8/16/2010
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U.S. FDA Panel Backs GlaxoSmithKline (GSK), Valeant Pharmaceuticals International (VRX) Epilepsy Drug; Glaxo Stock Rises
8/12/2010
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Cardiome Pharma Corp. (COM.TO) Says Heart Drug Program Delayed, Shares Fall
8/11/2010
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Momenta Pharmaceuticals, Inc. (MNTA) Announces FDA Approval for First Generic Lovenox(R); Shares Surge
7/26/2010
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US Panel Rejects Roche (RHHBY)'s Avastin for Breast Cancer
7/21/2010
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Amgen (AMGN) Gets Priority Review For Prolia
7/19/2010
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FDA Panel Rejects VIVUS, Inc. (VVUS) Diet Drug
7/16/2010
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FDA Panel Recommends Keeping GlaxoSmithKline (GSK)'s Avandia On US Market, But With More Warnings, Restrictions
7/15/2010
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Roche (RHHBY) Owned Genentech (RHHBY) Submits Breast Cancer Drug For FDA Approval; Roche Says Drug Could Rake in Sales of $1.88 Billion
7/7/2010
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FDA Approves Genentech (RHHBY)'s Lucentis(R) (Ranibizumab Injection) for the Treatment of Macular Edema Following Retinal Vein Occlusion
6/23/2010
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FDA Panel Votes Against NDA For Boehringer Ingelheim Corporation's 'Female Viagra' Flibanserin
6/21/2010
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FDA Approves Sanofi-Aventis (France) (SASY.PA) Prostate Cancer Drug
6/18/2010
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FDA Approves Novartis Corporation (NVS)'s Tasigna(R) For Newly Diagnosed Chronic Myeloid Leukemia Patients, Data Demonstrate Major Advance Over Gleevec(R)
6/18/2010
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New HRA Pharma "Morning-After" Pill Effective, Safe Say FDA Staff
6/15/2010
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FDA Panel Endorses Novartis AG Multiple Sclerosis Pill
6/11/2010
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FDA Approves Amgen (AMGN)'s Prolia(TM) (Denosumab) for Treatment of Postmenopausal Women With Osteoporosis at High Risk for Fracture
6/2/2010
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FDA Says Safe to Use GlaxoSmithKline (GSK)'s Rotarix, Merck & Co., Inc. (MRK)'s Rotateq
5/17/2010
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NicOx SA (COX.PA) Falls After Failing to Win FDA Panel's Backing Naproxcinod
5/13/2010
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Amylin Pharmaceuticals, Inc. (AMLN), Alkermes (ALKS), Eli Lilly and Company (LLY) BYDUREON (TM) FDA Review Timeline Set with PDUFA Action Date of October 22, 2010
5/6/2010
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FDA Rejects InterMune, Inc. (ITMN) Lung Drug, Shares Fell 74.96% @ Market Close on Wednesday, May 5
5/5/2010
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Sepracor, Inc. (SEPR), Subsidiary of Dainippon Sumitomo Pharma Co., Ltd., Fails to Win U.S. Approval of Epilepsy Drug STEDESA
5/4/2010
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US FDA Panel Rejects Acura Pharmaceuticals, Inc. And King Pharmaceuticals®, Inc.'s Painkiller Acurox
4/23/2010
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Novartis Pharmaceuticals Corporation (NVS) Receives US FDA Approval for Zortress(R) to Prevent Organ Rejection in Adult Kidney Transplant Recipients
4/22/2010
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FDA Mulls Killing GlaxoSmithKline (GSK)'s Avandia Safety Study
4/19/2010
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Roche (RHHBY), OSI Pharmaceuticals, Inc. (OSIP) Win U.S. Approval for Wider Tarceva Use
4/19/2010
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Amylin Pharmaceuticals, Inc. (AMLN), Eli Lilly and Company (LLY)'s Byetta May Have Cancer Risk, FDA Says
4/12/2010
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Cell Therapeutics, Inc. (CTIC) Receives Complete Response Letter from the FDA for Pixantrone NDA; FDA Recommends Additional Trial
4/9/2010
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US FDA Panel Rejects Forest Laboratories, Inc. (FRX), Nycomed Lung Drug
4/8/2010
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FDA Approves Salix Pharmaceuticals, Ltd. (SLXP) Drug Xifaxan For Liver Failure Disorder
3/25/2010
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US FDA Panel Rejects Cell Therapeutics, Inc. (CTIC) Lymphoma Drug
3/23/2010
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Somaxon Pharmaceuticals, Inc. Announces FDA Approval of Silenor(R) (Doxepin) For The Treatment Of Insomnia
3/18/2010
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FDA Delays Approval of Amylin Pharmaceuticals, Inc. (AMLN), Eli Lilly Canada Inc. (LLY) (JOBS) Diabetes Drug; FDA Requests Finalization of Product Labeling
3/15/2010
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FDA Requests Additional Information Regarding AFREZZA in Complete Response Letter to MannKind Corporation (MNKD)
3/15/2010
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FDA Advisory Committee Recommends Approval of InterMune, Inc. (ITMN)'s (JOBS) Esbriet(R) (pirfenidone) for Idiopathic Pulmonary Fibrosis
3/10/2010
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U.S. FDA Approves Shire plc's Drug for Gaucher Disease
3/1/2010
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FDA Approves Roche (RHHBY)'s Rituxan Plus Chemotherapy for the Most Common Type of Adult Leukemia
2/19/2010
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U.S. Denies Approval of XenoPort, Inc. (XNPT), GlaxoSmithKline (GSK) RLS Drug; Xenoport
2/18/2010
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Cadence Pharmaceuticals, Inc. Says FDA Refuses to OK Pain Drug
2/11/2010
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US FDA Staff Questions Cell Therapeutics, Inc. (CTIC) Lymphoma Drug Pixantrone Data
2/8/2010
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U.S. FDA Approves Labopharm (DDS.TO)'s Antidepressant Trazodone
2/3/2010
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US FDA Approves Acorda Therapeutics (ACOR) MS Drug to Help with Walking
1/25/2010
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Genzyme Corporation (GENZ) to Make Third Attempt at FDA Nod for Pompe Disease Drug
1/22/2010
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FDA Extends Review Period for OSI Pharmaceuticals, Inc. (OSIP)'sTarceva Application for First-Line Maintenance Use in Advanced Non-Small Cell Lung Cancer
1/15/2010
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FDA Panel Rejects New Use for Forest Laboratories, Inc. (FRX) (JOBS) Heart Drug
1/12/2010
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MAP Pharmaceuticals, Inc. (MAPP) (JOBS) Says FDA Waives Second Trial for Migraine Drug
1/11/2010
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FDA Approves Addition of Sustained Overall Survival Benefit to Label for Takeda Pharmaceutical Co. Ltd. (TKDG.DE)'s (JOBS) VELCADE(R) (Bortezomib) for Injection for Patients with Previously Untreated Multiple Myeloma
1/5/2010
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US Panel Backs Wider Use of AstraZeneca PLC (AZN)'s (JOBS) Crestor
12/16/2009
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Sanofi-Aventis (France) (SASY.PA) Recalls 800000 H1N1 Vaccine Over Potency
12/15/2009
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FDA Approves Eli Lilly and Company (LLY)'s (JOBS) ZYPREXA(R) RELPREVV(TM) for Treatment of Schizophrenia in Adults
12/14/2009
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Gilead Sciences, Inc. (GILD) (JOBS) Says FDA Advisory Committee Supports Use Of Aztreonam For Inhalation Solution For Patients With Cystic Fibrosis
12/11/2009
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U.S. FDA Panel Backs Novartis AG (JOBS) Transplant Drug
12/8/2009
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Dyax Corp. (DYAX) (JOBS) Gets FDA Approval For Genetic Disorder Drug
12/3/2009
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FDA Denies Approval for Theravance, Inc. (THRX)'s (JOBS) Pneumonia Drug
11/30/2009
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FDA Warns Heartburn Drugs Interfere with Sanofi-Aventis (France) (SASY.PA), Bristol-Myers Squibb Company (BMY)'s (JOBS) Plavix
11/18/2009
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Steel, Rubber Found in Some Genzyme Corporation (GENZ) Drugs
11/17/2009
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FDA Approves Xanodyne Pharmaceuticals, Inc.'s Lysteda to Treat Heavy Menstrual Bleeding
11/16/2009
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Elan Corporation PLC (ELN) (JOBS), Biogen Idec, Inc. (Massachusetts) (BIIB) (JOBS) Change Tysabri Label Due to PML Risk
11/10/2009
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FDA Approves Gloucester Pharmaceuticals, Inc.'s ISTODAX(R) for Patients with Cutaneous T-cell Lymphoma
11/6/2009
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FDA Won't Accept Merck & Co., Inc. (MRK)'s (JOBS) Application for New Drug
11/6/2009
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US FDA Delays Approval of Amgen (AMGN) (JOBS) Osteoporosis Drug
10/20/2009
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Genentech (South SF) (DNA) And Biogen Idec, Inc. (Massachusetts) (BIIB) Receive a Complete Response from FDA for Earlier Use of Rituxan for Rheumatoid Arthritis
10/20/2009
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FDA Approves GlaxoSmithKline (GSK)'s VOTRIENT(TM) for Advanced Renal Cell Cancer
10/20/2009
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FDA Approves Merck & Co., Inc. (MRK)'s (JOBS) GARDASIL(R) for Use in Boys and Young Men
10/19/2009
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FDA Approves URL Pharma's (JOBS) Colcrys(TM) for Prevention of Gout Flares
10/19/2009
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Acorda Therapeutics (ACOR) (JOBS) Announces Positive Vote by FDA Advisory Committee for Fampridine-SR
10/15/2009
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CSL Behring Announces FDA Approval of Berinert(R), First and Only Therapy Approved for the Treatment of Acute Abdominal and Facial Attacks of Hereditary Angioedema in U.S.
10/12/2009
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FDA Declines To Approve New Indication For Spectrum Pharmaceuticals, Inc. (SPPI) (JOBS) Fusilev; Shares Plunge
10/9/2009
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Allos Therapeutics, Inc. (ALTH) Cancer Drug Gets FDA Nod
9/25/2009
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FDA Advisory Committee Unanimously Recommends Approval of BioSpecifics Technologies Corporation (BSTC)'s XIAFLEX(TM) for Treatment of Dupuytren's Disease
9/17/2009
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FDA Panel Backs Auxilium Pharmaceuticals (AUXL) Hand Disorder Drug
9/17/2009
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US FDA Approves Sanofi-Aventis (France) (SASY.PA), CSL Limited (CMXHF.PK), MedImmune (JOBS), Novartis AG (JOBS) H1N1 Vaccine, Says Enough for Everyone
9/16/2009
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Theravance, Inc. (THRX) (JOBS) and Astellas Pharma Inc. (JOBS) Announce FDA Approval of VIBATIV(TM) for the Treatment of Complicated Skin and Skin Structure Infections
9/14/2009
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U.S. FDA to Review Mylan Inc. (MYL)'s Generic Copaxone
9/14/2009
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FDA Approves ISTA Pharmaceuticals, Inc. (ISTA)'s Itchy Eye Treatment Bepreve
9/9/2009
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FDA Advisory Committee Recommends Gloucester Pharmaceuticals, Inc.'s Romidepsin for Approval for Cutaneous T-cell Lymphoma
9/3/2009
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US FDA Approves Novartis Pharmaceuticals Corporation (NVS) (JOBS) Extavia(R) - the First in a New Portfolio of Planned MS Therapies from Novartis to Help Patients with this Devastating Disease
8/18/2009
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A Partial Approval for Amgen (AMGN)'s (JOBS) Osteoporosis Drug
8/17/2009
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Schering-Plough Corporation (SGP) (JOBS) Announces FDA Approval of SAPHRIS(R) (asenapine) for Acute Treatment of Schizophrenia in Adults and Manic or Mixed Episodes of Bipolar I Disorder
8/14/2009
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Novartis AG (JOBS) Hits Astellas Pharma Inc. (JOBS) with Transplant Drug Generic
8/11/2009
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AstraZeneca PLC (AZN) (JOBS), Bristol-Myers Squibb Company (BMY) (JOBS) Diabetes Drug Onglyza Wins U.S. OK
8/3/2009
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U.S. Panel Votes to Reject Johnson & Johnson (JNJ), Zeltia Group (18494051.MA) Cancer Drug, Yondelis
7/17/2009
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Eli Lilly and Company (LLY) (JOBS), Daiichi Sankyo Co Ltd. Receive U.S. FDA Approval for Effient(TM)
7/14/2009
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FDA will Review Amylin Pharmaceuticals, Inc. (AMLN), Eli Lilly and Company (LLY), and Alkermes (ALKS)' Exenatide Application
7/8/2009
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FDA Approves AMAG Pharmaceuticals, Inc. (AMAG)'s Feraheme(TM) to Treat Iron Deficiency Anemia in Adult Chronic Kidney Disease Patients
7/1/2009
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Takeda Pharmaceutical Co. Ltd. (TKDG.DE) Fails to Get U.S. Approval for Diabetes Drug
6/30/2009
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Cell Therapeutics, Inc. (CTIC) Completes Pixantrone NDA Submission and Requests Priority Review
6/25/2009
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FDA Will Not OK GlaxoSmithKline (GSK)'s (JOBS) Experimental Nausea Drug
6/24/2009
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FDA Panel to Meet August 13 on Amgen (AMGN)'s Denosumab Drug
6/24/2009
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US FDA Staff Urge Review of Abbott Laboratories (ABT) Drug Risks
6/22/2009
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Letter Urging the FDA to Halt its Review of Eli Lilly and Company (LLY) (JOBS) and Daiichi Sankyo Co Ltd. Prasugrel
6/4/2009
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Next Generation of Health Care Workers Train Through Medical Simulation
5/20/2009
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UCB Group (UCBJF.PK) Soars as U.S. Clears Key Arthritis Drug
5/14/2009
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New Warnings for Genentech, Inc. (DNA), OSI Pharmaceuticals, Inc. (OSIP) Tarceva Cancer Drug
5/11/2009
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FDA Adds Child Exposure Warnings to Solvay Pharmaceuticals, Inc., Auxilium Pharmaceuticals (AUXL) Testosterone Gel
5/8/2009
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Vanda Pharmaceuticals, Inc. (VNDA) Surges on Fanapt FDA Approval; Stock Up +625.93% at Market Close
5/7/2009
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VeroScience Announces FDA Approval of Cycloset for Treatment of Type 2 Diabetes
5/6/2009
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Genentech, Inc. (DNA) (JOBS) Pulls Psoriasis Drug Raptiva from Market for Safety
4/9/2009
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FDA Approves COARTEM with Priority Review Voucher; Voucher Market is Untested and Unclear
4/8/2009
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Novo Nordisk A/S (NVO)' Update on FDA Advisory Committee meeting on liraglutide for the treatment of type 2 diabetes
4/3/2009
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Bristol-Myers Squibb Company (BMY), AstraZeneca PLC (AZN) ONGLYZA (saxagliptin) Cardiovascular Profile Acceptable According to FDA Advisory Committee; Rival to Merck & Co., Inc. (MRK)'s Januvia Moves Closer to Approval
4/2/2009
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FDA Advisory Committee Unanimously Recommends Accelerated Approval of Genentech, Inc. (DNA)'s Avastin for Previously Treated Brain Cancer (Glioblastoma)
4/1/2009
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Intercell AG Announces FDA Approval of IXIARO(R), a Novel Vaccine to Prevent Japanese Encephalitis
3/31/2009
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Novo Nordisk A/S (NVO), AstraZeneca PLC (AZN)-Bristol-Myers Squibb Company (BMY) Diabetes Drugs Face U.S. Grilling
3/26/2009
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FDA Told To Reconsider Barr Pharmaceuticals, Inc. (BRL)'s Morning-After Pill Access
3/24/2009
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FDA Approves Eli Lilly and Company (LLY)'s Symbyax(R) as First Medication for Treatment-Resistant Depression
3/23/2009
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MannKind Corporation (MNKD) Submits NDA for AFRESA for Treatment of Diabetes
3/17/2009
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Takeda Pharmaceutical Co. Ltd. (TKDG.DE) Says FDA Needs More Data on Key Diabetes Drug
3/6/2009
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European Medicines Agency Recommends Suspension of Marketing Authorization for Genentech, Inc. (DNA) and Merck Serono's Raptiva(R)
2/19/2009
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Teijin Pharma and Takeda Pharmaceutical Co. Ltd. (TKDG.DE) Announce ULORIC Receives FDA Approval for the Chronic Management of Hyperuricemia in Patients with Gout
2/17/2009
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Savient Pharmaceuticals, Inc. (SVNT) Says FDA Extends Review of Gout Drug
2/13/2009
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U.S. Panel Backs Eli Lilly and Company (LLY) (JOBS), Daiichi Sankyo Co Ltd. (JOBS)
Anti-clotting Drug
2/4/2009
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Mylan Inc. (MYL) Receives FDA Approval for First-to-File Generic Depakote(R) ER
1/30/2009
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CSL Behring Receives FDA Approval of RiaSTAP(TM), First and Only Approved Treatment of Acute Bleeding Episodes in Patients with Congenital Fibrinogen Deficiency
1/20/2009
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Pfizer Inc. (PFE)'s (JOBS) Bone-Drug Fablyn Fails to Win U.S. Approval
1/20/2009
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Forest Laboratories, Inc. (FRX) and Cypress Bioscience Inc. (CYPB) Announce FDA Approval of Savella(TM) for the Management of Fibromyalgia
1/15/2009
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US FDA Backs Merck & Co., Inc. (MRK) (JOBS), Schering-Plough Corporation (SGP)'s (JOBS) Vytorin
1/9/2009
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FDA Advisory Committee Unanimously Recommends OVATION Pharmaceuticals, Inc.'s Sabril(R) (vigabatrin) for the Treatment of Two Catastrophic Epilepsies
1/9/2009
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Genzyme Corporation (GENZ) Approves {2}'s Mozobil
12/16/2008
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FDA Panel Urges Restrictions GlaxoSmithKline (GSK) (JOBS), Novartis Corporation (NVS) (JOBS) Asthma Drugs
12/12/2008
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Pain Therapeutics (PTIE) Receives Complete Response Letter From FDA for REMOXY(R): NDA is Not Approved
12/11/2008
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FDA Declines to Approve Targanta Therapeutics' Antibiotic
12/9/2008
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FDA Advisory Committee Recommends Approval of Allergan Inc. (AGN)'s First Prescription Eyelash Enhancer Latisse
12/5/2008
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{2} (JOBS) Hit as {1} Seeks More Data on Arthritis Drug
12/4/2008
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FDA Advisory Committee Provides Negative Opinion on Targanta Therapeutics' Oritavancin for the Treatment of Complicated Skin and Skin Structure Infections
11/20/2008
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FDA to Open China Offices After Product Scares
11/18/2008
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Gilead Sciences, Inc. (GILD) To Appeal FDA Cystic Fibrosis Trial Demand
11/14/2008
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AMAG Pharmaceuticals, Inc. Says FDA Accepts Anemia Drug Response; Shares Soar in Pre-Market Trade; FDA Establishes December 30, 2008 PDUFA Action Date
11/13/2008
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FDA Approves CV Therapeutics, Inc. (CVTX)'s Ranexa(R) for First Line Anti Anginal Use and Adds New Claims for Reduction of Ventricular Arrhythmias, Bradycardia, New Atrial Fibrillation and HbA1c
11/6/2008
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Amylin Pharmaceuticals, Inc. (AMLN) Sinks After U.S. FDA Rejects Data
11/4/2008
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FDA Extends Review of Pfizer Inc. (PFE) (JOBS) Osteoporosis Drug
10/22/2008
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AMAG Pharmaceuticals, Inc. Gets FDA Request for More Data on Anemia Drug
10/20/2008
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Daiichi Sankyo Co Ltd. and Eli Lilly and Company (LLY) New Drug Still on Track
10/17/2008
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Genentech, Inc. (DNA)'s (JOBS) Psoriasis Drug Raptiva Gets FDA Warning
10/17/2008
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InterMune, Inc. (ITMN) Reports Japanese Regulatory Approval of Pirfenidone in IPF
10/16/2008
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FDA Will Not Be Able To Complete Its Review Of Takeda Pharmaceutical Co. Ltd. (TKDG.DE)'s (JOBS) Alogliptin (SYR-322) NDA By The Prescription Drug User Fee Act (PDUFA) Date Of October 27, 2008; Delay Puts PPD, Inc. (PPDI) Payment On Hold
10/10/2008
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FDA to Spend $2.5 Billion on Technology Upgrade
10/1/2008
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Genentech, Inc. (DNA) (JOBS), OSI Pharmaceuticals, Inc. (OSIP) Warn Of Liver Damage From Tarceva, 2 Deaths
9/24/2008
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Pfizer Inc. (PFE) (JOBS), Boehringer Ingelheim Corporation Spiriva Linked with Risk of Cardiovascular Death and Stroke, According to Study
9/24/2008
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Decision Due Soon on Eli Lilly and Company (LLY) (JOBS), Daiichi Sankyo Co Ltd. Blood Thinner
9/22/2008
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FDA Delays Approval for Roche (RHHBY) (JOBS) Arthritis Drug, Actemra
9/19/2008
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Ranbaxy Laboratories Shares Drop 10% as U.S. Bans Drugs
9/17/2008
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Eli Lilly and Company (LLY), Amylin Pharmaceuticals, Inc. (AMLN) Diabetes Drug Linked to Two Deaths; FDA To Strengthen Warnings
8/19/2008
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Prestwick Pharmaceuticals, Inc.'s XENAZINE(R) Approved by FDA for Patients with Chorea Associated with Huntington's Disease
8/18/2008
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FDA Warns About Alkermes (ALKS) (JOBS), Cephalon, Inc. (CEPH) Alcoholism Drug
8/13/2008
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U.S. FDA Approves Gilead Sciences, Inc. (GILD)'s Viread(R) for Chronic Hepatitis B in Adults
8/12/2008
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Biogen Idec, Inc. (Massachusetts) (BIIB), Elan Corporation PLC (ELN) Report Tysabri Brain Disease Cases; Shares Fall
8/1/2008
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Amgen (AMGN) Blood-clotting Drug Decision Delayed
7/23/2008
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FDA Advisory Committee Provides Opinion of DORIBAX(TM) for the Treatment of Hospital-Acquired Pneumonia; Johnson and Johnson Pharmaceutical Research and Development, LLC (CA) (JOBS) Drug Gets Mixed Panel Vote
7/17/2008
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FDA (JOBS) Panel: No Black Box Warning On Epilepsy Drugs
7/11/2008
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FDA Revises Process for Responding to Drug Applications
7/9/2008
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FDA Panel Urges More Testing for Diabetes Drugs
7/2/2008
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FDA Advisory Committee Unanimously Recommends Approval of Centocor, Inc. (JNJ)'s Ustekinumab for Treatment of Moderate to Severe Plaque Psoriasis
6/18/2008
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FDA Approves Eli Lilly and Company (LLY)'s Cymbalta(R) for the Management of Fibromyalgia
6/16/2008
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Dendreon Corporation (DNDN) Release: Provenge Activists To Get Another Day In Court
6/9/2008
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Drugmakers: Moratorium On Advertising New Drugs
6/6/2008
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Genta Incorporated (GNTA) Submits NDA Amendment to FDA for Genasense as Treatment of Chronic Lymphocytic Leukemia
6/6/2008
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Adolor Corporation (ADLR) and GlaxoSmithKline (GSK) Announce FDA Approval of Entereg(R) (alvimopan) for the Management of Postoperative Ileus (POI)
5/21/2008
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InterMune, Inc. (ITMN) Announces Receipt of Fast Track Designation for Pirfenidone From FDA
5/19/2008
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FDA Sets Panel Review of GlaxoSmithKline (GSK) Clotting Drug According to Amgen (AMGN)
5/8/2008
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Astellas Pharma Inc. Says U.S. Not Ready to Approve Transplant Drug
5/7/2008
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Cephalon, Inc. (CEPH) Announces FDA Advisory Committee Recommendation Against Approval of an Expanded Label for FENTORA
5/7/2008
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FDA Approves Shire Pharmaceuticals Group plc (SHPGY)'s VYVANSE(TM), the First and Only Once-Daily Prodrug Stimulant to Treat ADHD in Adults
4/23/2008
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Genzyme Corporation (GENZ) Falls on Myozyme Approval Delay
4/22/2008
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Stromedix Raises $25 Million Series B for Fibrosis Programs, Begins Clinical Trial
4/21/2008
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FDA Approves Migraine Drug from GlaxoSmithKline (GSK), Pozen, Inc. (POZN)
4/16/2008
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Overview of FDA Meeting on Embryonic Stem Cells
4/10/2008
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FDA Gives Itself Okay To Miss Some Drug Approval Deadlines
3/17/2008
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Amgen (AMGN) and Wyeth (WYE) Announce Enbrel Drug Gets Black Box Infection-Risk Warning
3/17/2008
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FDA Indicates That Genta Incorporated (GNTA)'s Genasense(R) Approval in Chronic Lymphocytic Leukemia Will Require Additional Confirmatory Data
3/17/2008
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U.S. Advisers: Restrict Amgen (AMGN), Johnson & Johnson (JNJ) Anemia Drugs
3/13/2008
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Johnson and Johnson Pharmaceutical Research and Development, LLC (NJ) Says FDA Delays Antibiotic Review by 3 Months
3/7/2008
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More Evidence of Danger From Bayer AG (BAY) Heart Surgery Drug
2/21/2008
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Commenting on the U.S. FDA Early Communication, Allergan Inc. (AGN) Clarifies FDA's Inquiry Relates Primarily to High Dose Medical Uses of BOTOX(R), Rather Than BOTOX(R) Cosmetic for Aesthetic Use
2/11/2008
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FDA Issues Health Advisory on Pfizer Inc. (PFE)'s Chantix Tablets
2/4/2008
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Teva Pharmaceutical Industries Limited (TEVA) Provides Update on Generic Protonix(R)
2/1/2008
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US FDA to Review Vytorin Cholesterol Drug Study
1/28/2008
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FDA Approves Biogen, Inc. and Elan Corporation PLC (ELN)'s TYSABRI(R) for the Treatment of Moderate-to-Severe Crohn's Disease
1/15/2008
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FDA Declares Cloned Meat, Milk Safe
1/15/2008
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FDA: "Bio-identical" Hormone Claims Unsupported
1/10/2008
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Forest Laboratories, Inc. (FRX) and Cypress Bioscience Inc. (CYPB) Announce Submission of New Drug Application for Milnacipran for the Treatment of Fibromyalgia Syndrome
12/31/2007
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Neurocrine Biosciences, Inc. (NBIX) Gets FDA Approvable Letter for Indiplon
12/13/2007
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BioMarin Pharmaceutical Inc. (BMRN) Announces FDA Approval for Kuvan First Specific Drug Therapy Approved for the Treatment of PKU
12/13/2007
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FDA Advisory Committee Recommends Approval of Cardiome Pharma Corp. (COM.TO) and Astellas Pharma US, Inc.'s (Jobs) KYNAPID(TM) for Acute Atrial Fibrillation
12/12/2007
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Amgen (AMGN), FDA Discussing Anemia Drug Label Changes
12/7/2007
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US Panel Rejects Genentech, Inc. (DNA)'s Avastin for Treating Breast Cancer
12/5/2007
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FDA Updates Boxed Warning for GlaxoSmithKline (GSK)'s Avandia
11/14/2007
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Genzyme Corporation (GENZ) Receives FDA Response Letter on Synvisc-One(TM) Approval in U.S. to be Delayed
11/13/2007
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Amgen (AMGN) Strengthens Warnings on Anemia Drug Labels
11/8/2007
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Momenta Pharmaceuticals, Inc. (MNTA) Says U.S. FDA Rejects its Generic Lovenox
11/6/2007
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FDA Adds Warning to Cephalon, Inc. (CEPH)'s Provigil Sleep Drug
10/25/2007
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FDA Advisory Committee Recommends Medtronic, Inc. (MDT) (Jobs)'s Endeavor(R) Drug-Eluting Stent for Approval
10/11/2007
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ZymoGenetics, Inc. (ZGEN) (Jobs) and Merck Serono Receive FDA Special Protocol Assessment for Atacicept Pivotal Study in Lupus Nephritis
10/4/2007
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Amylin Pharmaceuticals, Inc. (AMLN) (Jobs) Says SYMLIN Pen-Injector Devices Use Without Mealtime Insulin Not Approvable
10/1/2007
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Vanda Pharmaceuticals, Inc. (VNDA) Submits Iloperidone New Drug Application
9/27/2007
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MGI PHARMA, INC. (MOGN) Announces Submission of Aquavan(R) New Drug Application
9/27/2007
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