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BioPharm Executive - Rockville Files
Celgene Corporation (CELG) Wins FDA Approval For Pill To Treat Psoriatic Arthritis 3/25/2014  More...
Novartis AG (NVS) Announces FDA Approval Of Xolair® (Omalizumab) For Chronic Idiopathic Urticaria (CIU), A Form Of Chronic Hives 3/24/2014  More...
Pfizer Inc. (PFE)'s Meningitis Vaccine Wins Breakthrough Status From The FDA 3/20/2014  More...
National Institute of Clinical Research Turns Down Celgene (CELG)'s Revlimid 3/17/2014  More...
Chelsea Therapeutics, Inc. (CHTP) Pops As FDA Finally Approves NORTHERA™ 2/19/2014  More...
FDA Approves Booming BioMarin Pharmaceutical Inc. (BMRN)'s VIMIZIM™ 2/19/2014  More...
Pharmacyclics, Inc. (PCYC)'s Imbruvica Wins Second Cancer Approval 2/13/2014  More...
GlaxoSmithKline (GSK)'s Promacta Wins Breakthrough Therapy Designation By FDA 2/5/2014  More...
FDA Approves Vanda Pharmaceuticals, Inc. (VNDA)'s Sleep Disorder Drug HETLIOZ™ 2/3/2014  More...
FDA Panel Once Again Rejects Wider Use Of Johnson & Johnson (JNJ) Drug 1/17/2014  More...
Merck & Co., Inc. (MRK)'s Blood Thinner, Vorapaxar, Gets "Yes" Vote From FDA Panel 1/16/2014  More...
AstraZeneca PLC (AZN), Bristol-Myers Squibb Company (BMY)'s New Approach Diabetes Drug, Farxiga™, Wins FDA Approval 1/10/2014  More...
United Therapeutics Corporation (UTHR) Hits All-Time High As FDA OKs Lung Disease Drug; Stock Up +30.36% At Market Close (Dec. 23, 2013) 12/27/2013  More...
GlaxoSmithKline (GSK)'s Malaria Drug Wins FDA "Breakthrough" Status 12/23/2013  More...
FDA Panel Backs AstraZeneca PLC (AZN), Bristol-Myers Squibb Company (BMY)'s Diabetes Drug Dapagliflozin After Initial Rebuff 12/13/2013  More...
FDA Panel Has Split Vote On Bristol-Myers Squibb Company (BMY)'s Fat Disorder Drug Metreleptin 12/13/2013  More...
FDA Approves Gilead Sciences, Inc. (GILD)'s Sovaldi™, A $1,000-A-Day Hepatitis C Pill 12/11/2013  More...
FDA Approves BioSpecifics Technologies Corporation (BSTC)'s First Drug Treatment For Peyronie's Disease 12/6/2013  More...
EU Agency Starts In-Depth Review Of Ariad Pharmaceuticals, Inc. (ARIA) Leukemia Drug 12/6/2013  More...
BioMarin Pharmaceutical Inc. (BMRN) Wins FDA Panel's Blessing For Rare Disease Drug 11/20/2013  More...
Johnson & Johnson (JNJ), Pharmacyclics, Inc. (PCYC) Breakthrough Drug Wins FDA Approval 11/18/2013  More...
Investors Can Sleep Soundly As FDA Panel Backs Vanda Pharmaceuticals, Inc. (VNDA)'s Drug For The Blind 11/15/2013  More...
Sarepta Therapeutics (Formerly known as AVI BioPharma, Inc.) (SRPT) Crumbles as FDA Wants More Testing Of Muscular Disease Drug Eteplirsen; Stock Down -64.01% At Market Close (November 12, 2013) 11/13/2013  More...
Genentech (RHHBY) Grabs Breakthrough Approval for Chronic Leukemia Drug Gazyva 11/5/2013  More...
FDA Panel Backs Gilead Sciences, Inc. (GILD) Hepatitis C Drug Sofosbuvir 10/29/2013  More...
Merck & Co., Inc. (MRK) Hep C Combo Gets Breakthrough Status 10/25/2013  More...
FDA Approves Actelion Ltd. (ALIOF.PK)'s Opsumit to Treat Pulmonary Arterial Hypertension 10/21/2013  More...
FDA Approves Bayer HealthCare Pharmaceuticals (BAYA.F)'s New Class of Drug Adempas® (riociguat) Tablets to Treat Adults With PAH and Persistent, Recurrent or Inoperable CTEPH 10/9/2013  More...
Pfizer Inc. (PFE), Ligand Pharmaceuticals Inc. (LGND)'s Hot-Flash, Osteoporosis Drug Duavee Gets FDA Approval 10/7/2013  More...
Bayer AG (BAYN.DE) Grabs Approval for Adempas® as First Drug to Treat Rare Heart and Lung Disease 9/24/2013  More...
GlaxoSmithKline (GSK) Leaps Forward With Melanoma Treatment After FDA Ruling 9/17/2013  More...
FDA Grants Breakthrough Status for GlaxoSmithKline (GSK), Genmab A/S (GEN.CO)'s Arzerra®; Genmab Stock Soars +9.94% at Market Close (September 16, 2013) 9/17/2013  More...
FDA Panels Gives Nod to Accelerated Approval of Genentech (RHHBY)'s Perjeta for Early Stage Breast Cancer 9/16/2013  More...
FDA Approves Celgene Corporation (CELG)'s ABRAXANE® for Metastatic Pancreatic Cancer 9/9/2013  More...
FDA Grants "Breakthrough Status" to Novartis AG (NVS)'s Muscle Wasting Drug 8/22/2013  More...
FDA Approves GlaxoSmithKline (GSK)'s HIV Drug 8/14/2013  More...
FDA Advisory Panel Backs Bayer HealthCare Pharmaceuticals (BAYA.F)'s Riociguat for Lung Disease 8/7/2013  More...
FDA's Cardiovascular and Renal Drugs Advisory Committee Recommends Not to Approve Otsuka Pharmaceutical Co., Ltd.'s Tolvaptan for Use in Autosomal Dominant Polycystic Kidney Disease (ADPKD) 8/6/2013  More...
Boehringer Ingelheim Corporation's Gilotrif Wins FDA OK for Advanced Lung Cancer 7/15/2013  More...
GlaxoSmithKline (GSK) Catches Analysts Off-Guard and Files Melanoma Drug Combo Early in Race to Market 7/11/2013  More...
Johnson & Johnson (JNJ), Pharmacyclics, Inc. (PCYC) Submits NDA for Breakthrough Drug Ibrutinib 7/10/2013  More...
FDA Puts Achillion Pharmaceuticals, Inc. (ACHN) Hepatitis C Drug on Clinical Hold 7/3/2013  More...
FDA OKs Hisamitsu Pharmaceutical's First Nonhormonal Drug for Hot Flashes 7/2/2013  More...
FDA Rejects AVEO Oncology (Formerly known as AVEO Pharmaceuticals, Inc.) (AVEO)'s Kidney Cancer Drug, Asks for Additional Trial 6/11/2013  More...
Obama Administration Reverses Course on Teva Pharmaceutical Industries Limited (TEVA)'s Plan B Pill 6/11/2013  More...
Celgene (CELG)'s Revlimid Wins FDA Lymphoma Approval 6/7/2013  More...
Depomed, Inc. (DEPO) Abandons Menopause Drug After FDA Rejection 6/3/2013  More...
FDA Approves Two GlaxoSmithKline (GSK) Melanoma Drugs 5/31/2013  More...
Bayer AG (BAY.F), Algeta Win FDA Approval for Prostate Cancer Drug 5/16/2013  More...
Genentech (RHHBY) Wins New FDA OK for Lung Cancer Drug, Diagnostic Test 5/15/2013  More...
FDA Approves GlaxoSmithKline (GSK)/Theravance, Inc. (THRX) Drug for COPD Lung Disease 5/13/2013  More...
Gilead Sciences, Inc. (GILD) Fails FDA Approval for Two HIV Drugs in 4-in-1 Pill 5/6/2013  More...
FDA Approves Genentech (RHHBY)'s ACTEMRA® for Children Living With a Rare Form of Arthritis 5/1/2013  More...
FDA Panel Backs Approval of GlaxoSmithKline (GSK), Theravance, Inc. (THRX) Lung Drug 4/22/2013  More...
GlaxoSmithKline (GSK)'s Avandia Gets Second Look at Heart Risk by U.S. 4/12/2013  More...
Gilead Sciences, Inc. (GILD) Pushes for FDA Blockbuster Approval 4/11/2013  More...
Johnson & Johnson (JNJ), Pharmacyclics, Inc. (PCYC) Gets New Breakthrough-Therapy Designation for Ibrutinib 4/8/2013  More...
Biogen Idec, Inc. (Massachusetts) (BIIB) Wins FDA Approval for Blockbuster Oral MS Drug 3/28/2013  More...
Novartis AG (NVS) Breast Cancer Drug Rejected Despite Being Hailed as a "Breakthrough" 3/25/2013  More...
FDA Rejects Pharmaxis Ltd (PXS.AX) Drug Push Bid 3/19/2013  More...
Heart Warning Added to Pfizer Inc. (PFE)s "Z-Pak" Antibiotic by FDA 3/13/2013  More...
FDA Panel Rejects Depomed, Inc. (DEPO) Menopause Treatment 3/5/2013  More...
FDA Approves Shionogi, Inc.'s Drug for Painful Intercourse in Women 2/27/2013  More...
FDA Approves Genentech (RHHBY)'s Drug for Late-Stage Metastatic Breast Cancer 2/26/2013  More...
FDA Approves Novartis AG (NVS)'s Zortress to Prevent Liver Transplant Rejection 2/19/2013  More...
FDA Approves Celgene Corporation (CELG)'s Pomalyst for Advanced Multiple Myeloma 2/12/2013  More...
Hemispherx Biopharma (HEB) Says FDA Rejects Fatigue Drug Application 2/5/2013  More...
FDA Panel Backs Boehringer Ingelheim Corporation COPD Drug 1/31/2013  More...
Allergan Inc. (AGN)'s Botox Gets FDA Approval for Overactive Bladder 1/23/2013  More...
NuPathe Inc. (PATH) Shares Jump After FDA Approves Migraine Patch 1/21/2013  More...
Santarus Inc. (SNTS) Wins FDA Approval for Ulcerative Colitis Therapy; Will Add 85 New Sales Reps to Support Drug 1/17/2013  More...
FDA Panel Backs Johnson & Johnson (JNJ)'s Risky Diabetes Drug 1/14/2013  More...
Bristol-Myers Squibb Company (BMY)-Pfizer Inc. (PFE)'s Blood Thinner Eliquis Wins FDA Approval 1/3/2013  More...
Ariad Pharmaceuticals, Inc. (ARIA) Wins FDA Approval for Drug to Treat Rare Leukemias 12/18/2012  More...
Johnson & Johnson (JNJ)'s Zytiga Wins Approval for Early Prostate Cancer Use 12/11/2012  More...
Sanofi Pasteur (SASY.PA)'s Meningococcus Vaccine Menactra Approved for Infants Down to 9 Months 12/3/2012  More...
Exelixis, Inc. (EXEL)'s FDA Approves Cometriq to Treat Rare Type of Thyroid Cancer 12/3/2012  More...
Theravance, Inc. (THRX) Halted; FDA Panel to Review VIBATIV NDA 11/30/2012  More...
Dynavax Technologies Corporation (DVAX) Falls After Vaccine Fails to Win Panel Backing 11/19/2012  More...
FDA Approves Pfizer Inc. (PFE)'s Rheumatoid Arthritis Pill 11/9/2012  More...
Novo Nordisk A/S (NVO) Upbeat on Tresiba Insulin's U.S. Prospects 11/9/2012  More...
FDA Panel Gives Unanimous OK to Novartis AG (NVS)'s Cushing's Drug 11/8/2012  More...
Novo Nordisk A/S (NVO)'s Insulin Tresiba Has Heart Safety Risks, FDA Says 11/6/2012  More...
FDA Approves Teva Pharmaceutical Industries Limited (TEVA) Leukemia Drug 10/30/2012  More...
FDA Approves Eisai Inc. (ESALF.PK) Drug for Epileptic Seizures 10/24/2012  More...
FDA Panel Backs Sanofi (France) (SAN.PA) and Isis Pharmaceuticals, Inc. (ISIS) Drug for Rare Genetic Disorder 10/22/2012  More...
Aegerion Pharmaceuticals, Inc. (AEGR) Soars as FDA Panel Backs Cholesterol Drug 10/19/2012  More...
FDA: ThromboGenics NV (TBGNF) Main Drug Cleared for U.S. Launch 10/18/2012  More...
Johnson & Johnson (JNJ)'s Janssen Biotech Inc. Unit Submits BLA for Anti-TNF)-alpha SIMPONI 9/19/2012  More...
Sanofi (France) (SAN.PA)'s Genzyme Corporation (GENZ) Wins FDA Approval for Multiple Sclerosis Pill 9/14/2012  More...
Amarin Corporation PLC (AMRN) Still Awaits FDA OK for Heart Drug 9/11/2012  More...
FDA Approves Pfizer Inc. (PFE)'s Leukemia Drug 9/6/2012  More...
FDA Approves Teva Pharmaceutical Industries Limited (TEVA) Copycat of Amgen (AMGN)'s Neupogen 8/31/2012  More...
FDA Approves Roche (RHHBY)'s Lucentis to Treat Diabetic Macular Edema 8/10/2012  More...
FDA Approves Talon Therapeutics, Inc. (TLON.OB)'s Marqibo to Treat Rare Type of Leukemia 8/10/2012  More...
FDA Approves First Generic Copies of Merck & Co., Inc. (MRK)'s Singulair 8/7/2012  More...
GlaxoSmithKline (GSK) Files Two Melanoma Drugs for U.S., Europe Approvals 8/6/2012  More...
FDA Approves Sanofi (France) (SAN.PA)-Regeneron Pharmaceuticals, Inc. (REGN)'s Zaltrap for Metastatic Colorectal Cancer 8/6/2012  More...
FDA OKs Onyx Pharmaceuticals, Inc. (ONXX)'s Kyprolis for Multiple Myeloma 7/23/2012  More...
FDA Approves Novartis AG (NVS)'s Afinitor for Breast Cancer 7/20/2012  More...
FDA Approves VIVUS, Inc. (VVUS)'s Weight-Loss Pill 7/19/2012  More...
FDA Approves Gilead Sciences, Inc. (GILD)'s Truvada Pill for HIV Prevention 7/17/2012  More...
FDA Approves Arena Pharmaceuticals, Inc. (ARNA) Obesity Drug; First in 13 Years 6/28/2012  More...
Onyx Pharmaceuticals, Inc. (ONXX) Surges on FDA Panel Vote for Blood-Cancer Drug 6/22/2012  More...
Celgene (CELG) Revlimid Growth Plans Stopped Dead 6/21/2012  More...
FDA OKs Roche (RHHBY)'s New Breast Cancer Drug 6/13/2012  More...
FDA Delays Its Decision on Gilead Sciences, Inc. (GILD)'s Anti-HIV Pill 6/11/2012  More...
Merck & Co., Inc. (MRK)/Ariad Pharmaceuticals, Inc. (ARIA) Fails to Win FDA OK for Sarcoma Drug 6/7/2012  More...
FDA Panel Split on Pfizer Inc. (PFE) Rare Disease Drug 5/29/2012  More...
Astellas Pharma Inc. (YPH.BE)/Medivation, Inc. (MDVN) File Prostate Cancer Drug in USA 5/22/2012  More...
Gilead Sciences, Inc. (GILD)' HIV Quad Pill Wins Backing From FDA Advisers 5/15/2012  More...
Arena Pharmaceuticals, Inc. (ARNA) Wins Positive FDA Panel Vote for Obesity Drug 5/14/2012  More...
Medgenics, Inc. Announces First Quarter 2012 Financial Results 5/14/2012  More...
FDA OKs VIVUS, Inc. (VVUS)'s Fast-acting Viagra Rival 5/1/2012  More...
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  More...
Watson Pharmaceuticals, Inc. (WPI) Launches Generic FORTAMET(R) 4/20/2012  More...
VIVUS, Inc. (VVUS) Weight-Loss Drug Qnexa Gets Three-Month Delay for FDA Review 4/11/2012  More...
Astellas Pharma Inc. (ALPMY) Wins FDA Panel Backing for Overactive Bladder Drug 4/6/2012  More...
Talon Therapeutics, Inc. (HNAB)' Marqibo(R) Wins Backing of FDA Advisory Panel 3/23/2012  More...
Shire plc Drops After Pulling US Application for Replagal, Move Gives Sanofi (France) (SAN.PA) a Boost 3/16/2012  More...
FDA Approves Discovery Laboratories (DSCO) Respiratory Drug for Preemies 3/8/2012  More...
Pfizer Inc. (PFE) Pulls Plug on FDA Application for Pristiq 3/2/2012  More...
FDA Approves Aptalis Pharmaceutical Technologies' 2 Drugs for Rare Digestive Disorders 3/2/2012  More...
FDA Panel Backs Forest Laboratories, Inc. (FRX),Almirall COPD Drug 2/27/2012  More...
VIVUS, Inc. (VVUS) Doubles After Winning Panel Backing for First Weight-Loss Pill in 13 Years 2/24/2012  More...
Amgen (AMGN) Fails to Win Panel Backing for Expanded Xgeva Use FDA 2/10/2012  More...
FDA Approves Vertex Pharmaceuticals (MA) (VRTX)'s Cystic Fibrosis Drug 2/1/2012  More...
FDA Approves Genentech (RHHBY)'s Erivedge (Vismodegib) Capsule, the First Medicine for Adults with Advanced Basal Cell Carcinoma 1/31/2012  More...
FDA Rejects AstraZeneca PLC (AZN)'s and Bristol-Myers Squibb Company (BMY)'s Dapagliflozin for Type 2 Diabetes 1/20/2012  More...
FDA Approves BTG plc (BGC.L)'s Drug for Cancer Toxicity 1/19/2012  More...
FDA Approves Gilead Sciences, Inc. (GILD) NDA for Viread in HIV-Infected Children 1/19/2012  More...
Seattle Genetics, Inc. (SGEN) Lymphoma Drug Gets Boxed Warning on Brain Infection Risk 1/18/2012  More...
FDA to Review Pfizer Inc. (PFE) Rheumatoid Arthritis Drug 12/21/2011  More...
FDA Panel Gives Nod to Johnson & Johnson (JNJ) Drug for Anemia 12/12/2011  More...
FDA: Boehringer Ingelheim Corporation's Pradaxa Benefit Outweighs Bleeding Risk 12/8/2011  More...
FDA OKs Antares Pharma, Inc. (AIS) Overactive Bladder Gel 12/8/2011  More...
FDA Panel Backs Pfizer Inc. (PFE)'s Drug for Kidney Cancer 12/7/2011  More...
Pfizer Inc. (PFE)'s Kidney Cancer Drug May Not Be Effective, FDA Says 12/7/2011  More...
FDA Approves Transcept Pharmaceuticals, Inc. (TSPT)'s Intermezzo, the First Insomnia Drug for Middle-of-The-Night Waking 11/28/2011  More...
Regeneron Pharmaceuticals, Inc. (REGN) Wins FDA Approval for Blindness Drug Eylea 11/22/2011  More...
EUSA Pharma Announces FDA Approval of Orphan Drug ERWINAZE(TM) for Treatment of Acute Lymphoblastic Leukemia 11/18/2011  More...
FDA Panel Backs Pfizer Inc. (PFE) Vaccine for Adults 11/17/2011  More...
FDA Approves Incyte Corporation (INCY)’s Jakafi(TM) (ruxolitinib) for Rare Bone-Marrow Disease 11/17/2011  More...
Eli Lilly and Company (LLY), Amylin Pharmaceuticals, Inc. (AMLN) Diabetes Drug Wins Approval for Expanded Use 10/21/2011  More...
VIVUS, Inc. (VVUS) Resubmits FDA App for Obesity Drug Qnexa 10/18/2011  More...
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  More...
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  More...
Transcept Pharmaceuticals, Inc. (TSPT) Shares Soar on Potential Sleeping Pill Approval; Intermezzo(R) PDUFA Action Date of November 27, 2011 10/5/2011  More...
FDA Approves Alexza Pharmaceuticals, Inc. (ALXA)'s Soliris for Rare Pediatric Blood Disorder 9/26/2011  More...
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  More...
Orexigen Therapeutics, Inc. (OREX) Surges After Revival of Obesity Drug Rejected by FDA Begins 9/22/2011  More...
FDA Approves Amgen (AMGN)'s Prolia the Go-Ahead in Two Cancer Therapy-Induced Bone Loss Indications 9/21/2011  More...
FDA Panel Gives Nod to Bayer HealthCare (BAY)/Johnson & Johnson (JNJ) Anti-clot Drug 9/12/2011  More...
FDA Approves Seattle Genetics, Inc. (SGEN) Cancer Drug Adcetris to Treat Two Types of Lymphoma 8/23/2011  More...
FDA Approves Roche (RHHBY)'s Skin Cancer Drug Zelboraf 8/19/2011  More...
Regeneron Pharmaceuticals, Inc. (REGN) Falls on FDA Delay of Eye Drug 8/18/2011  More...
FDA Approves Gilead Sciences, Inc. (GILD)'s Once-Daily HIV Treatment Complera 8/12/2011  More...
Amylin Pharmaceuticals, Inc. (AMLN), Eli Lilly and Company (LLY) and Alkermes (ALKS)'s BYDUREON Reply Submitted to FDA 8/1/2011  More...
FDA Approves AstraZeneca PLC (AZN) Heart Drug Brilinta 7/25/2011  More...
FDA Panel Rejects AstraZeneca PLC (AZN), Bristol-Myers Squibb Company (BMY) Diabetes Pill 7/20/2011  More...
National Institute for Clinical Excellence (NICE) Proposes to Disapprove the Use of the Drug Novartis AG's Lucentis; Diabetes Groups Outraged 7/19/2011  More...
FDA Panel Backs Seattle Genetics, Inc. (SGEN) Lymphoma Drug Adcetris 7/14/2011  More...
Roche (RHHBY) Loses UK Appeal Over Long-term Tarceva Use 6/29/2011  More...
FDA Panel Rejects Novartis AG (NVS) Drug for Gout 6/23/2011  More...
FDA Panel Unanimously Backs Approval Of Regeneron Pharmaceuticals, Inc. (REGN) Eye Drug 6/21/2011  More...
EU Beats FDA, Approves Eli Lilly and Company (LLY)'s Weekly Diabetes Drug Bydureon 6/21/2011  More...
FDA Approves Bristol-Myers Squibb Company (BMY)'s Drug That Prevents Organ Rejection 6/16/2011  More...
Orexigen Therapeutics, Inc. (OREX) To Halt US Obesity Program as it Disputes FDA Contrave Request 6/3/2011  More...
FDA Approves Vertex Pharmaceuticals (MA) (VRTX)'s INCIVEK(TM) (telaprevir) for People with Hepatitis C 5/24/2011  More...
FDA Clears Merck & Co., Inc. (MRK)'s Victrelis for Hepatitis C, First New Hep C Drug Approved in 20 Years 5/16/2011  More...
Roche (RHHBY) Seeks Approvals for New Skin Cancer Drug 5/11/2011  More...
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  More...
VIVUS, Inc. (VVUS) to Submit Qnexa Application as Limited Indication 5/3/2011  More...
FDA Approves Genentech (RHHBY)'s Actemra to Treat Rare Form of Juvenile Arthritis 4/18/2011  More...
Eli Lilly and Company (LLY)'s BYDUREON Recommended for Approval in Europe 4/15/2011  More...
Pfizer Inc. (PFE) and Novartis Corporation (NVS) Drugs Get FDA Panel Recommendation 4/13/2011  More...
Optimer Pharmaceuticals, Inc. (OPTR) Wins FDA Advisory Panel's Backing for Fidaxomicin for Treatment of Patients With Clostridium difficile Infection (CDI) 4/7/2011  More...
FDA Approves AstraZeneca PLC (AZN)'s New Treatment for Rare Form of Thyroid Cancer 4/7/2011  More...
FDA Approves New Bristol-Myers Squibb Company (BMY) Treatment for a Type of Late-Stage Skin Cancer 3/28/2011  More...
Neurosearch A/S (NEUR.CO) Shares Plunge as FDA Wants More Data 3/24/2011  More...
Novartis AG (NVS) Receives EU Approval for Gilenya 3/21/2011  More...
Human Genome Sciences, Inc. (HGSI) and GlaxoSmithKline (GSK) Announce FDA Approval of BENLYSTA(R) (Belimumab) for Treatment of Systemic Lupus Erythematosus 3/11/2011  More...
Forest Laboratories, Inc. (FRX), Nycomed Get Approval for Lung Drug, Roflumilast 3/1/2011  More...
FDA Approves Exelixis, Inc. (EXEL) Product to Prevent Bleeding in People With Rare Genetic Defect 2/18/2011  More...
Gilead Sciences, Inc. (GILD) Refiles New Drug Application with the FDA for Single-Tablet Regimen of Truvada(R) and TMC278 2/11/2011  More...
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  More...
U.S. FDA Rejects Orexigen Therapeutics, Inc. (OREX) Diet Drug Over Heart Risks 2/2/2011  More...
FDA Approves Genentech (RHHBY)'s Rituxan for First-Line Maintenance Use in Follicular Lymphoma 1/31/2011  More...
Depomed, Inc. (DEPO)'s Shingles Drug Gets OK from FDA 1/31/2011  More...
Clinical Data Announces FDA Approval of Viibryd(TM) (vilazodone HCl) for Major Depressive Disorder 1/24/2011  More...
FDA Wants Birth-Defect Data from VIVUS, Inc. (VVUS) for Qnexa 1/21/2011  More...
FDA Rejects MannKind Corporation (MNKD) Diabetes Device, Afrezza 1/20/2011  More...
FDA Panel Rejects Eli Lilly and Company (LLY) Pancreatic-Enzyme Replacement 1/13/2011  More...
Amylin Pharmaceuticals, Inc. (AMLN) and Eli Lilly and Company (LLY) Seek Expanded Use of BYETTA(R) Along with Basal Insulin 12/27/2010  More...
Roche (RHHBY) Drug Avastin Rejected by U.K. Agency National Institute for Clinical Excellence (NICE) for Use in Breast Cancer 12/8/2010  More...
FDA Panel Endorses Orexigen Therapeutics, Inc. (OREX) Weight-Loss Drug Contrave 12/8/2010  More...
FDA Declines to Approve GlaxoSmithKline (GSK) and Valeant Pharmaceuticals International (VRX)'s Epilepsy Drug 12/3/2010  More...
FDA Panel Backs AstraZeneca LP (AZN)'s Drug, Vandetanib, For Rare Thyroid Cancer but Asked to Rethink Drug Dosage 12/3/2010  More...
Merck & Co., Inc. (MRK)’s Proscar Fails to Win U.S. FDA Panel’s Backing for Prostate Cancer 12/2/2010  More...
FDA Panel Backs Human Genome Sciences, Inc. (HGSI)'s Drug, Benlysta for Lupus 11/17/2010  More...