FDA Panel Backs Approval of GlaxoSmithKline (GSK), Theravance, Inc. (THRX) Lung Drug
4/22/2013
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GlaxoSmithKline (GSK)'s Avandia Gets Second Look at Heart Risk by U.S.
4/12/2013
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Gilead Sciences, Inc. (GILD) Pushes for FDA Blockbuster Approval
4/11/2013
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Johnson & Johnson (JNJ), Pharmacyclics, Inc. (PCYC) Gets New Breakthrough-Therapy Designation for Ibrutinib
4/8/2013
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Biogen Idec, Inc. (Massachusetts) (BIIB) Wins FDA Approval for Blockbuster Oral MS Drug
3/28/2013
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Novartis AG (NVS) Breast Cancer Drug Rejected Despite Being Hailed as a "Breakthrough"
3/25/2013
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FDA Rejects Pharmaxis Ltd (PXS.AX) Drug Push Bid
3/19/2013
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Heart Warning Added to Pfizer Inc. (PFE)s "Z-Pak" Antibiotic by FDA
3/13/2013
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FDA Panel Rejects Depomed, Inc. (DEPO) Menopause Treatment
3/5/2013
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FDA Approves Shionogi, Inc.'s Drug for Painful Intercourse in Women
2/27/2013
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FDA Approves Genentech (RHHBY)'s Drug for Late-Stage Metastatic Breast Cancer
2/26/2013
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FDA Approves Novartis AG (NVS)'s Zortress to Prevent Liver Transplant Rejection
2/19/2013
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FDA Approves Celgene Corporation (CELG)'s Pomalyst for Advanced Multiple Myeloma
2/12/2013
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Hemispherx Biopharma (HEB) Says FDA Rejects Fatigue Drug Application
2/5/2013
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FDA Panel Backs Boehringer Ingelheim Corporation COPD Drug
1/31/2013
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Allergan Inc. (AGN)'s Botox Gets FDA Approval for Overactive Bladder
1/23/2013
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NuPathe Inc. (PATH) Shares Jump After FDA Approves Migraine Patch
1/21/2013
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Santarus Inc. (SNTS) Wins FDA Approval for Ulcerative Colitis Therapy; Will Add 85 New Sales Reps to Support Drug
1/17/2013
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FDA Panel Backs Johnson & Johnson (JNJ)'s Risky Diabetes Drug
1/14/2013
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Bristol-Myers Squibb Company (BMY)-Pfizer Inc. (PFE)'s Blood Thinner Eliquis Wins FDA Approval
1/3/2013
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Ariad Pharmaceuticals, Inc. (ARIA) Wins FDA Approval for Drug to Treat Rare Leukemias
12/18/2012
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Johnson & Johnson (JNJ)'s Zytiga Wins Approval for Early Prostate Cancer Use
12/11/2012
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Sanofi Pasteur (SASY.PA)'s Meningococcus Vaccine Menactra Approved for Infants Down to 9 Months
12/3/2012
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Exelixis, Inc. (EXEL)'s FDA Approves Cometriq to Treat Rare Type of Thyroid Cancer
12/3/2012
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Theravance, Inc. (THRX) Halted; FDA Panel to Review VIBATIV NDA
11/30/2012
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Dynavax Technologies Corporation (DVAX) Falls After Vaccine Fails to Win Panel Backing
11/19/2012
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Novo Nordisk A/S (NVO) Upbeat on Tresiba Insulin's U.S. Prospects
11/9/2012
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FDA Approves Pfizer Inc. (PFE)'s Rheumatoid Arthritis Pill
11/9/2012
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FDA Panel Gives Unanimous OK to Novartis AG (NVS)'s Cushing's Drug
11/8/2012
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Novo Nordisk A/S (NVO)'s Insulin Tresiba Has Heart Safety Risks, FDA Says
11/6/2012
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FDA Approves Teva Pharmaceutical Industries Limited (TEVA) Leukemia Drug
10/30/2012
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FDA Approves Eisai Inc. (ESALF.PK) Drug for Epileptic Seizures
10/24/2012
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FDA Panel Backs Sanofi (France) (SAN.PA) and Isis Pharmaceuticals, Inc. (ISIS) Drug for Rare Genetic Disorder
10/22/2012
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Aegerion Pharmaceuticals, Inc. (AEGR) Soars as FDA Panel Backs Cholesterol Drug
10/19/2012
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FDA: ThromboGenics NV (TBGNF) Main Drug Cleared for U.S. Launch
10/18/2012
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Johnson & Johnson (JNJ)'s Janssen Biotech Inc. Unit Submits BLA for Anti-TNF)-alpha SIMPONI
9/19/2012
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Sanofi (France) (SAN.PA)'s Genzyme Corporation (GENZ) Wins FDA Approval for Multiple Sclerosis Pill
9/14/2012
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Amarin Corporation PLC (AMRN) Still Awaits FDA OK for Heart Drug
9/11/2012
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FDA Approves Pfizer Inc. (PFE)'s Leukemia Drug
9/6/2012
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FDA Approves Teva Pharmaceutical Industries Limited (TEVA) Copycat of Amgen (AMGN)'s Neupogen
8/31/2012
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FDA Approves Roche (RHHBY)'s Lucentis to Treat Diabetic Macular Edema
8/10/2012
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FDA Approves Talon Therapeutics, Inc. (TLON.OB)'s Marqibo to Treat Rare Type of Leukemia
8/10/2012
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FDA Approves First Generic Copies of Merck & Co., Inc. (MRK)'s Singulair
8/7/2012
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GlaxoSmithKline (GSK) Files Two Melanoma Drugs for U.S., Europe Approvals
8/6/2012
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FDA Approves Sanofi (France) (SAN.PA)-Regeneron Pharmaceuticals, Inc. (REGN)'s Zaltrap for Metastatic Colorectal Cancer
8/6/2012
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FDA OKs Onyx Pharmaceuticals, Inc. (ONXX)'s Kyprolis for Multiple Myeloma
7/23/2012
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FDA Approves Novartis AG (NVS)'s Afinitor for Breast Cancer
7/20/2012
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FDA Approves VIVUS, Inc. (VVUS)'s Weight-Loss Pill
7/19/2012
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FDA Approves Gilead Sciences, Inc. (GILD)'s Truvada Pill for HIV Prevention
7/17/2012
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FDA Approves Arena Pharmaceuticals, Inc. (ARNA) Obesity Drug; First in 13 Years
6/28/2012
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Onyx Pharmaceuticals, Inc. (ONXX) Surges on FDA Panel Vote for Blood-Cancer Drug
6/22/2012
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Celgene (CELG) Revlimid Growth Plans Stopped Dead
6/21/2012
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FDA OKs Roche (RHHBY)'s New Breast Cancer Drug
6/13/2012
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FDA Delays Its Decision on Gilead Sciences, Inc. (GILD)'s Anti-HIV Pill
6/11/2012
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Merck & Co., Inc. (MRK)/Ariad Pharmaceuticals, Inc. (ARIA) Fails to Win FDA OK for Sarcoma Drug
6/7/2012
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FDA Panel Split on Pfizer Inc. (PFE) Rare Disease Drug
5/29/2012
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Astellas Pharma Inc. (YPH.BE)/Medivation, Inc. (MDVN) File Prostate Cancer Drug in USA
5/22/2012
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Gilead Sciences, Inc. (GILD)' HIV Quad Pill Wins Backing From FDA Advisers
5/15/2012
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Medgenics, Inc. Announces First Quarter 2012 Financial Results
5/14/2012
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Arena Pharmaceuticals, Inc. (ARNA) Wins Positive FDA Panel Vote for Obesity Drug
5/14/2012
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FDA OKs VIVUS, Inc. (VVUS)'s Fast-acting Viagra Rival
5/1/2012
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AMAG Pharmaceuticals, Inc. (AMAG) Gets Initial EU Nod, Potentially Bagging a $30 Million Milestone Payment From Takeda Pharmaceutical Co. Ltd. (TKDG.DE)
4/23/2012
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Watson Pharmaceuticals, Inc. (WPI) Launches Generic FORTAMET(R)
4/20/2012
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VIVUS, Inc. (VVUS) Weight-Loss Drug Qnexa Gets Three-Month Delay for FDA Review
4/11/2012
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Astellas Pharma Inc. (YPH.BE) Wins FDA Panel Backing for Overactive Bladder Drug
4/6/2012
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Talon Therapeutics, Inc. (HNAB)' Marqibo(R) Wins Backing of FDA Advisory Panel
3/23/2012
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Shire plc Drops After Pulling US Application for Replagal, Move Gives Sanofi (France) (SAN.PA) a Boost
3/16/2012
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FDA Approves Discovery Laboratories (DSCO) Respiratory Drug for Preemies
3/8/2012
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Pfizer Inc. (PFE) Pulls Plug on FDA Application for Pristiq
3/2/2012
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FDA Approves Aptalis Pharmaceutical Technologies' 2 Drugs for Rare Digestive Disorders
3/2/2012
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FDA Panel Backs Forest Laboratories, Inc. (FRX),Almirall COPD Drug
2/27/2012
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VIVUS, Inc. (VVUS) Doubles After Winning Panel Backing for First Weight-Loss Pill in 13 Years
2/24/2012
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Amgen (AMGN) Fails to Win Panel Backing for Expanded Xgeva Use FDA
2/10/2012
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FDA Approves Vertex Pharmaceuticals (MA) (VRTX)'s Cystic Fibrosis Drug
2/1/2012
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FDA Approves Genentech (RHHBY)'s Erivedge (Vismodegib) Capsule, the First Medicine for Adults with Advanced Basal Cell Carcinoma
1/31/2012
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FDA Rejects AstraZeneca PLC (AZN)'s and Bristol-Myers Squibb Company (BMY)'s Dapagliflozin for Type 2 Diabetes
1/20/2012
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FDA Approves Gilead Sciences, Inc. (GILD) NDA for Viread in HIV-Infected Children
1/19/2012
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FDA Approves BTG plc (BGC.L)'s Drug for Cancer Toxicity
1/19/2012
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Seattle Genetics, Inc. (SGEN) Lymphoma Drug Gets Boxed Warning on Brain Infection Risk
1/18/2012
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FDA to Review Pfizer Inc. (PFE) Rheumatoid Arthritis Drug
12/21/2011
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FDA Panel Gives Nod to Johnson & Johnson (JNJ) Drug for Anemia
12/12/2011
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FDA OKs Antares Pharma, Inc. (AIS) Overactive Bladder Gel
12/8/2011
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FDA: Boehringer Ingelheim Corporation's Pradaxa Benefit Outweighs Bleeding Risk
12/8/2011
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FDA Panel Backs Pfizer Inc. (PFE)'s Drug for Kidney Cancer
12/7/2011
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Pfizer Inc. (PFE)'s Kidney Cancer Drug May Not Be Effective, FDA Says
12/7/2011
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FDA Approves Transcept Pharmaceuticals, Inc. (TSPT)'s Intermezzo, the First Insomnia Drug for Middle-of-The-Night Waking
11/28/2011
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Regeneron Pharmaceuticals, Inc. (REGN) Wins FDA Approval for Blindness Drug Eylea
11/22/2011
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EUSA Pharma Announces FDA Approval of Orphan Drug ERWINAZE(TM) for Treatment of Acute Lymphoblastic Leukemia
11/18/2011
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FDA Panel Backs Pfizer Inc. (PFE) Vaccine for Adults
11/17/2011
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FDA Approves Incyte Corporation (INCY)’s Jakafi(TM) (ruxolitinib) for Rare Bone-Marrow Disease
11/17/2011
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Eli Lilly and Company (LLY), Amylin Pharmaceuticals, Inc. (AMLN) Diabetes Drug Wins Approval for Expanded Use
10/21/2011
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VIVUS, Inc. (VVUS) Resubmits FDA App for Obesity Drug Qnexa
10/18/2011
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FDA Approves Merck & Co., Inc. (MRK)'s Combination Therapy Juvisync; First Combination Drug to Treat type 2 Diabetes and High Cholesterol in one Tablet
10/10/2011
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FDA Approves Boehringer Ingelheim Corporation's Combivent(R) Respimat(R) (ipratropium bromide and albuterol) Inhalation Spray for the Treatment of Patients with Chronic Obstructive Pulmonary Disease
10/10/2011
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Transcept Pharmaceuticals, Inc. (TSPT) Shares Soar on Potential Sleeping Pill Approval; Intermezzo(R) PDUFA Action Date of November 27, 2011
10/5/2011
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FDA Approves Alexza Pharmaceuticals, Inc. (ALXA)'s Soliris for Rare Pediatric Blood Disorder
9/26/2011
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European CHMP Adopts Positive Opinion for Gilead Sciences, Inc. (GILD)'s Eviplera(R), a Once-Daily Single-Tablet Regimen for the Treatment of HIV Infection
9/23/2011
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Orexigen Therapeutics, Inc. (OREX) Surges After Revival of Obesity Drug Rejected by FDA Begins
9/22/2011
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FDA Approves Amgen (AMGN)'s Prolia the Go-Ahead in Two Cancer Therapy-Induced Bone Loss Indications
9/21/2011
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FDA Panel Gives Nod to Bayer HealthCare (BAY)/Johnson & Johnson (JNJ) Anti-clot Drug
9/12/2011
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FDA Approves Seattle Genetics, Inc. (SGEN) Cancer Drug Adcetris to Treat Two Types of Lymphoma
8/23/2011
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FDA Approves Roche (RHHBY)'s Skin Cancer Drug Zelboraf
8/19/2011
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Regeneron Pharmaceuticals, Inc. (REGN) Falls on FDA Delay of Eye Drug
8/18/2011
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FDA Approves Gilead Sciences, Inc. (GILD)'s Once-Daily HIV Treatment Complera
8/12/2011
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Amylin Pharmaceuticals, Inc. (AMLN), Eli Lilly and Company (LLY) and Alkermes (ALKS)'s BYDUREON Reply Submitted to FDA
8/1/2011
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FDA Approves AstraZeneca PLC (AZN) Heart Drug Brilinta
7/25/2011
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FDA Panel Rejects AstraZeneca PLC (AZN), Bristol-Myers Squibb Company (BMY) Diabetes Pill
7/20/2011
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National Institute for Clinical Excellence (NICE) Proposes to Disapprove the Use of the Drug Novartis AG's Lucentis; Diabetes Groups Outraged
7/19/2011
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FDA Panel Backs Seattle Genetics, Inc. (SGEN) Lymphoma Drug Adcetris
7/14/2011
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Roche (RHHBY) Loses UK Appeal Over Long-term Tarceva Use
6/29/2011
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FDA Panel Rejects Novartis AG (NVS) Drug for Gout
6/23/2011
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FDA Panel Unanimously Backs Approval Of Regeneron Pharmaceuticals, Inc. (REGN) Eye Drug
6/21/2011
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EU Beats FDA, Approves Eli Lilly and Company (LLY)'s Weekly Diabetes Drug Bydureon
6/21/2011
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FDA Approves Bristol-Myers Squibb Company (BMY)'s Drug That Prevents Organ Rejection
6/16/2011
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Orexigen Therapeutics, Inc. (OREX) To Halt US Obesity Program as it Disputes FDA Contrave Request
6/3/2011
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FDA Approves Vertex Pharmaceuticals (MA) (VRTX)'s INCIVEK(TM) (telaprevir) for People with Hepatitis C
5/24/2011
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FDA Clears Merck & Co., Inc. (MRK)'s Victrelis for Hepatitis C, First New Hep C Drug Approved in 20 Years
5/16/2011
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Roche (RHHBY) Seeks Approvals for New Skin Cancer Drug
5/11/2011
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Novartis AG (NVS) Gains FDA Approval for Afinitor(R) as First New Treatment in Nearly Three Decades for Patients with Advanced Pancreatic NET
5/6/2011
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VIVUS, Inc. (VVUS) to Submit Qnexa Application as Limited Indication
5/3/2011
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FDA Approves Genentech (RHHBY)'s Actemra to Treat Rare Form of Juvenile Arthritis
4/18/2011
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Eli Lilly and Company (LLY)'s BYDUREON Recommended for Approval in Europe
4/15/2011
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Pfizer Inc. (PFE) and Novartis Corporation (NVS) Drugs Get FDA Panel Recommendation
4/13/2011
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Optimer Pharmaceuticals, Inc. (OPTR) Wins FDA Advisory Panel's Backing for Fidaxomicin for Treatment of Patients With Clostridium difficile Infection (CDI)
4/7/2011
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FDA Approves AstraZeneca PLC (AZN)'s New Treatment for Rare Form of Thyroid Cancer
4/7/2011
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FDA Approves New Bristol-Myers Squibb Company (BMY) Treatment for a Type of Late-Stage Skin Cancer
3/28/2011
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Neurosearch A/S (NEUR.CO) Shares Plunge as FDA Wants More Data
3/24/2011
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Novartis AG (NVS) Receives EU Approval for Gilenya
3/21/2011
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Human Genome Sciences, Inc. (HGSI) and GlaxoSmithKline (GSK) Announce FDA Approval of BENLYSTA(R) (Belimumab) for Treatment of Systemic Lupus Erythematosus
3/11/2011
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Forest Laboratories, Inc. (FRX), Nycomed Get Approval for Lung Drug, Roflumilast
3/1/2011
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FDA Approves Exelixis, Inc. (EXEL) Product to Prevent Bleeding in People With Rare Genetic Defect
2/18/2011
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Gilead Sciences, Inc. (GILD) Refiles New Drug Application with the FDA for Single-Tablet Regimen of Truvada(R) and TMC278
2/11/2011
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FDA Approves KV Pharmaceutical Company (KV-A)'s Makena, the First and Only Treatment to Reduce the Risk of Preterm Birth in Women With a Singleton Pregnancy Who Have a History of Singleton Spontaneous Preterm Birth
2/4/2011
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U.S. FDA Rejects Orexigen Therapeutics, Inc. (OREX) Diet Drug Over Heart Risks
2/2/2011
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FDA Approves Genentech (RHHBY)'s Rituxan for First-Line Maintenance Use in Follicular Lymphoma
1/31/2011
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Depomed, Inc. (DEPO)'s Shingles Drug Gets OK from FDA
1/31/2011
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Clinical Data Announces FDA Approval of Viibryd(TM) (vilazodone HCl) for Major Depressive Disorder
1/24/2011
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FDA Wants Birth-Defect Data from VIVUS, Inc. (VVUS) for Qnexa
1/21/2011
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FDA Rejects MannKind Corporation (MNKD) Diabetes Device, Afrezza
1/20/2011
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FDA Panel Rejects Eli Lilly and Company (LLY) Pancreatic-Enzyme Replacement
1/13/2011
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Amylin Pharmaceuticals, Inc. (AMLN) and Eli Lilly and Company (LLY) Seek Expanded Use of BYETTA(R) Along with Basal Insulin
12/27/2010
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FDA Panel Endorses Orexigen Therapeutics, Inc. (OREX) Weight-Loss Drug Contrave
12/8/2010
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Roche (RHHBY) Drug Avastin Rejected by U.K. Agency National Institute for Clinical Excellence (NICE) for Use in Breast Cancer
12/8/2010
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FDA Declines to Approve GlaxoSmithKline (GSK) and Valeant Pharmaceuticals International (VRX)'s Epilepsy Drug
12/3/2010
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FDA Panel Backs AstraZeneca LP (AZN)'s Drug, Vandetanib, For Rare Thyroid Cancer but Asked to Rethink Drug Dosage
12/3/2010
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Merck & Co., Inc. (MRK)’s Proscar Fails to Win U.S. FDA Panel’s Backing for Prostate Cancer
12/2/2010
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FDA Panel Backs Human Genome Sciences, Inc. (HGSI)'s Drug, Benlysta for Lupus
11/17/2010
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Roche (RHHBY)'s Avastin Rejected by U.K. Agency for Colorectal Cancer
11/15/2010
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Eli Lilly and Company (LLY) Wins Approval to Use Antidepressant Cymbalta for Back, Arthritis Pain
11/5/2010
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Cadence Pharmaceuticals, Inc. Announces FDA Approval of OFIRMEV(TM) (acetaminophen) Injection for the Management of Pain and Fever; the Only IV Form of the Drug
11/3/2010
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FDA Nixes VIVUS, Inc. (VVUS)’s Qnexa; Asks For More Safety Data
10/29/2010
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Arena Pharmaceuticals, Inc. (ARNA) Obesity Drug Fails to Win FDA Approval, May Need More Clinical Testing
10/26/2010
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FDA Warns On Possible Heart, Diabetes Risk With Prostate Cancer Drugs Including Abbott Laboratories (ABT)' Lupron, AstraZeneca PLC (AZN)'s Zoladex, Sanofi-Aventis (France) (SASY.PA)'s Eligard, and Pfizer Inc. (PFE)'s Synarel
10/22/2010
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FDA Approves Roche Holding AG (RHHBF.PK) Drug Herceptin For Advanced Stomach Cancer
10/21/2010
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FDA Seeks More Data On Amylin Pharmaceuticals, Inc. (AMLN), Eli Lilly and Company (LLY) and Alkermes (ALKS) Diabetes Drug
10/21/2010
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FDA Approves Boehringer Ingelheim Pharmaceuticals, Inc.'s Pradaxa to Reduce the Risk of Stroke in Patients with Non-Valvular Atrial Fibrillation
10/20/2010
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Talecris Biotherapeutics (TLCR) Receives FDA Approval for Gamunex(R)-C
10/15/2010
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Merck KGaA (MKGAF.PK) MS Pill Cladribine Rejected by European Medicines Evaluation Agency
9/24/2010
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Novartis AG Gets First U.S. Approval for MS Drug Gilenya; Novartis Ahead of Merck KGaA (MKGAF.PK) in Race to Get to Market
9/23/2010
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FDA Significantly Restricts Access to GlaxoSmithKline (GSK)'s Diabetes Drug Avandia; Europeans Pull Plug
9/23/2010
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FDA Panel Endorses Novartis AG Multiple Sclerosis Pill
9/22/2010
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US Advisers Reject Arena Pharmaceuticals, Inc. (ARNA) Diet Drug Lorcaserin
9/17/2010
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U.S. Panel Splits On Abbott Laboratories (ABT) Diet Drug Ban
9/16/2010
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FDA Approves Savient Pharmaceuticals, Inc. (SVNT)'s KRYSTEXXA(TM) (pegloticase) for the Treatment of Chronic Gout in Adult Patients Refractory to Conventional Therapy
9/15/2010
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Genentech (RHHBY), ImmunoGen, Inc. (IMGN) Receives Refuse to File Letter from FDA for Drug T-DM1
8/30/2010
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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 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 plc (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., 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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