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BioPharm Executive - Rockville Files
Pfizer (PFE) Snags FDA Breakthrough Therapy Tag for Xalkori 4/21/2015
Analysts Cheer As Amgen (AMGN) Nabs Long-Awaited FDA Approval of Heart Failure Drug Corlanor 4/16/2015
Momenta Pharmaceuticals, Inc. (MNTA) Announces FDA Approval Of ANDA For Glatopa (Glatiramer Acetate Injection), The First Substitutable Generic For COPAXONE (Glatiramer Acetate Injection) 20mg 4/16/2015
Gilead (GILD)'s Next-Gen HIV Drug Heads to the FDA, Stock Soars 4/10/2015
Clovis Oncology (CLVS) Shares Leap as FDA Deems Ovarian Cancer Drug a Breakthrough, Company Preps for ARIEL3 4/8/2015
FDA Panel Backs GlaxoSmithKline (GSK), Theravance (THRX)'s Breo for Adults, Not Kids 3/23/2015
United Therapeutics Corporation (UTHR) Release: FDA Approves Unituxin (dinutuximab) For The Treatment Of Pediatric High-Risk Neuroblastoma 3/10/2015
Astellas Pharma Inc. (ALPMY) Receives FDA Approval for CRESEMBA (isavuconazonium sulfate) For The Treatment Of Invasive Aspergillosis And Invasive Mucormycosis 3/9/2015
Novartis AG (NVS)'s Sandoz Bags Approval for First Biosimilar to be Sold in the U.S. 3/9/2015
Actavis (ACT) Receives U.S. FDA Approval For AVYCAZ (CEFTAZIDIME-AVIBACTAM) 2/26/2015
23andMe Wins FDA Approval for First Genetic Test Kit 2/26/2015
FDA Approves Eisai Company (ESALY.PK)'s LENVIMA (Lenvatinib) For The Treatment Of Patients With Locally Recurrent Or Metastatic, Progressive, Radioactive Iodine-Refractory Differentiated Thyroid Cancer 2/16/2015
FDA Green Lights Pfizer (PFE)'s High Profile Breast Cancer Drug Two Months Early 2/5/2015
bluebird bio (BLUE)'s Rare Blood Disorder Drug Tagged a Breakthrough by the FDA 2/3/2015
Intercept Pharmaceuticals (ICPT) Rockets as Lead NASH Drug Snags Breakthrough Status From the FDA 2/2/2015
f-Star Approves Novartis AG (NVS)'s Cosentyx for Painful Skin Disease 1/23/2015
FDA Green Lights Daiichi Sankyo (DSNKY)'s New Anti-Clotting Drug 1/9/2015
Novartis AG (NVS) Submits Two Lung Drugs for FDA Approval; Analysts Question Decision 1/8/2015
Actavis (ACT), Adamas Pharmaceuticals (ADMS) Win FDA Approval for Alzheimer's Drug Namzaric 1/5/2015
Amgen (AMGN) Wins FDA Approval For New XGEVA Indication 12/9/2014
FDA Grants Breakthrough Therapy Status To Takeda Pharmaceutical Co. Ltd. (TKPYY)'s Ixazomib 12/8/2014
Speedy FDA Approval For Amgen (AMGN)'s Leukemia Immunotherapy BLINCYTO 12/5/2014
FDA Requires Additional Data On Bristol-Myers Squibb Company (BMY)' Hep C Daclatasvir 11/26/2014
Juno Therapeutics (JUNO) T Cell Therapy For Leukemia Granted FDA Breakthrough Therapy Designation 11/25/2014
Regeneron (REGN), ReGen Therapeutics Plc (RGT.L) Eczema Drug Dupilumab Gets FDA Breakthrough Therapy Designation 11/24/2014
France Strikes Deal For Gilead Sciences, Inc. (GILD)'s Hep C Drug Sovaldi 11/21/2014
FDA Approves Roche (RHHBY)’s Avastin Plus Chemotherapy To Treat Women With Platinumresistant Recurrent Ovarian Cancer 11/17/2014
FDA Approves Genzyme Corporation (GENZ)’s Lemtrada For MS 11/17/2014
Spark Therapeutics (ONCE) Snags FDA Breakthrough Therapy Designation For Lead Product 11/6/2014
RSD Selected By Leading Global Biotechnology Company For Information Governance 10/27/2014
FDA Panel Unanimously Backs Novartis AG (NVS)' Psoriasis Drug 10/22/2014
Vertex Pharmaceuticals (MA) (VRTX) Surges As FDA Advisory Panel Approves Kalydeco's Label Expansion 10/22/2014
Boehringer Ingelheim Corporation Wins FDA Approval For Lung Disease Drug Ofev 10/17/2014
InterMune, Inc. (ITMN) Wins FDA Approval For Lung Drug At Center Of Roche (RHHBY) Deal 10/17/2014
FDA Approves Gilead Sciences, Inc. (GILD)'s New Hepatitis C Drug Harvoni 10/15/2014
FDA Approves AstraZeneca PLC (AZN), Nektar Therapeutics (CA) (NKTR)'s MOVANTIK™ For Opioid-Induced Constipation 9/16/2014
FDA Panel Recommends Approval Of NPS Pharmaceuticals, Inc. (NPSP)'s Natpara To Treat Hypoparathyroidism 9/15/2014
FDA Approves Orexigen Therapeutics, Inc. (OREX)'s Long-Awaited Weight Loss Drug Contrave 9/12/2014
National Institute for Clinical Excellence (NICE) Rejects Celgene (CELG)'s Abraxane For Pancreatic Cancer Over Limited Benefits, Cost 9/9/2014
FDA Approves Merck & Co. (MRK)'s New-Kind Of Cancer Drug Keytruda 9/8/2014
FDA Approves Genzyme Corporation (GENZ)'s Gaucher Disease Pill Cerdelga 8/20/2014
FDA Approves Biogen Idec, Inc. (Massachusetts) (BIIB)'s Multiple Sclerosis Drug Plegridy 8/19/2014
Merck & Co. (MRK) Wins FDA Approval For New Type Of Sleeping Pill 8/15/2014
FDA Approves The Medicines Company (MDCO)'s Acute Skin Infection Drug Orbactiv 8/7/2014
FDA Green Lights Boehringer Ingelheim Corporation, Eli Lilly and Company (LLY)'s Jardiance For Type 2 Diabetes 8/1/2014
FDA Approves Gilead Sciences, Inc. (GILD)'s Zydelig® (idelalisib) For Relapsed Chronic Lymphocytic Leukemia, Follicular Lymphoma And Small Lymphocytic Lymphoma 7/23/2014
Vertex Pharmaceuticals (MA) (VRTX)'s $300,000 A Year Drug Is Denied, And Medicaid Patients Sue 7/18/2014
Pharming Group (PHGUF.PK), Salix (SLXP) Wins FDA Approval For Ruconest® 7/17/2014
FDA Approves Anacor Pharmaceuticals, Inc. (ANAC)’ KERYDIN™ (Tavaborole) Topical Solution, 5% For The Treatment Of Onychomycosis Of The Toenails 7/8/2014
FDA Green Lights Spectrum Pharmaceuticals, Inc. (SPPI)'s Beleodag To Treat Rare Form Of Lymphoma 7/3/2014
Cubist Pharmaceuticals, Inc. (CBST) Wins FDA Approval For MRSA Antibiotic Sivextro 6/24/2014
Successful Phase 3 Results For Alkermes plc (ALKS)'s Schizophrenia Drug Aripiprazole Lauroxil 6/19/2014
FDA Approves Valeant Pharmaceuticals International (VRX) Toenail Fungus Drug Jublia® 6/9/2014
FDA Approves Biogen, Inc.'s Hemophilia A Drug Eloctate 6/9/2014
Genentech (RHHBY) Bladder Cancer Med Anti-PDL1 (MPDL3280A) Nabs Breakthrough Status 6/9/2014
Amgen (AMGN) Colorectal Cancer Drug Vectibix Gains Expanded Approval From The FDA 5/28/2014
Takeda Pharmaceutical Co. Ltd. (TKPYY)'s Entyvio Wins FDA Approval For Severe Colitis 5/22/2014
Clovis Oncology (CLVS) Wins Breakthrough Status For Lung Cancer Candidate CO-1686 5/21/2014
GlaxoSmithKline (GSK) Touts Positive Incruse™-Ellipta®-Advair®-Diskus® Combo Data 5/20/2014
Merck & Co., Inc. (MRK) Release: FDA Approves ZONTIVITY™ (Vorapaxar), First-In-Class PAR-1 Antagonist, For The Reduction Of Thrombotic Cardiovascular Events In Patients With A History Of Heart Attack Or With Peripheral Arterial Disease 5/12/2014
AstraZeneca PLC (AZN) Gets A Lift In Pfizer Inc. (PFE) Fight As FDA Approves Heart Pill Epanova 5/7/2014
FDA Approves Eli Lilly and Company (LLY)'s Cyramza For Stomach Cancer 4/23/2014
QRxPharma Ltd. (QRXPY) Fails To Win Panel Backing For New Painkiller Moxduo 4/23/2014
FDA Approves GlaxoSmithKline (GSK)'s Tanzeum To Treat Type 2 Diabetes 4/15/2014
San Diego's Celladon Corporation Grabs FDA's “Breakthrough Therapy” Status for Gene Therapy 4/11/2014
MannKind Corporation (MNKD) Rockets As FDA Panel Backs Inhaled Diabetes Drug Afrezza; Stock Up 73.88% At Market Close (April 2, 2014) 4/4/2014
Celgene Corporation (CELG) Wins FDA Approval For Pill To Treat Psoriatic Arthritis 3/25/2014
Novartis AG (NVS) Announces FDA Approval Of Xolair® (Omalizumab) For Chronic Idiopathic Urticaria (CIU), A Form Of Chronic Hives 3/24/2014
Pfizer Inc. (PFE)'s Meningitis Vaccine Wins Breakthrough Status From The FDA 3/20/2014
National Institute of Clinical Research Turns Down Celgene (CELG)'s Revlimid 3/17/2014
FDA Approves Booming BioMarin Pharmaceutical Inc. (BMRN)'s VIMIZIM™ 2/19/2014
Chelsea Therapeutics, Inc. (CHTP) Pops As FDA Finally Approves NORTHERA™ 2/19/2014
Pharmacyclics, Inc. (PCYC)'s Imbruvica Wins Second Cancer Approval 2/13/2014
GlaxoSmithKline (GSK)'s Promacta Wins Breakthrough Therapy Designation By FDA 2/5/2014
FDA Approves Vanda Pharmaceuticals, Inc. (VNDA)'s Sleep Disorder Drug HETLIOZ™ 2/3/2014
FDA Panel Once Again Rejects Wider Use Of Johnson & Johnson (JNJ) Drug 1/17/2014
Merck & Co. (MRK)'s Blood Thinner, Vorapaxar, Gets "Yes" Vote From FDA Panel 1/16/2014
AstraZeneca PLC (AZN), Bristol-Myers Squibb Company (BMY)'s New Approach Diabetes Drug, Farxiga™, Wins FDA Approval 1/10/2014
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
GlaxoSmithKline (GSK)'s Malaria Drug Wins FDA "Breakthrough" Status 12/23/2013
FDA Panel Backs AstraZeneca PLC (AZN), Bristol-Myers Squibb Company (BMY)'s Diabetes Drug Dapagliflozin After Initial Rebuff 12/13/2013
FDA Panel Has Split Vote On Bristol-Myers Squibb Company (BMY)'s Fat Disorder Drug Metreleptin 12/13/2013
FDA Approves Gilead Sciences, Inc. (GILD)'s Sovaldi™, A $1,000-A-Day Hepatitis C Pill 12/11/2013
FDA Approves BioSpecifics Technologies Corporation (BSTC)'s First Drug Treatment For Peyronie's Disease 12/6/2013
EU Agency Starts In-Depth Review Of Ariad Pharmaceuticals, Inc. (ARIA) Leukemia Drug 12/6/2013
BioMarin Pharmaceutical Inc. (BMRN) Wins FDA Panel's Blessing For Rare Disease Drug 11/20/2013
Johnson & Johnson (JNJ), Pharmacyclics, Inc. (PCYC) Breakthrough Drug Wins FDA Approval 11/18/2013
Investors Can Sleep Soundly As FDA Panel Backs Vanda Pharmaceuticals, Inc. (VNDA)'s Drug For The Blind 11/15/2013
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
Genentech (RHHBY) Grabs Breakthrough Approval for Chronic Leukemia Drug Gazyva 11/5/2013
FDA Panel Backs Gilead Sciences, Inc. (GILD) Hepatitis C Drug Sofosbuvir 10/29/2013
Merck & Co., Inc. (MRK) Hep C Combo Gets Breakthrough Status 10/25/2013
FDA Approves Actelion Ltd. (ALIOF.PK)'s Opsumit to Treat Pulmonary Arterial Hypertension 10/21/2013
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
Pfizer Inc. (PFE), Ligand Pharmaceuticals Inc. (LGND)'s Hot-Flash, Osteoporosis Drug Duavee Gets FDA Approval 10/7/2013
Bayer AG (BAYN.DE) Grabs Approval for Adempas® as First Drug to Treat Rare Heart and Lung Disease 9/24/2013
GlaxoSmithKline (GSK) Leaps Forward With Melanoma Treatment After FDA Ruling 9/17/2013
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
FDA Panels Gives Nod to Accelerated Approval of Genentech (RHHBY)'s Perjeta for Early Stage Breast Cancer 9/16/2013
FDA Approves Celgene Corporation (CELG)'s ABRAXANE® for Metastatic Pancreatic Cancer 9/9/2013
FDA Grants "Breakthrough Status" to Novartis AG (NVS)'s Muscle Wasting Drug 8/22/2013
FDA Approves GlaxoSmithKline (GSK)'s HIV Drug 8/14/2013
FDA Advisory Panel Backs Bayer HealthCare Pharmaceuticals (BAYA.F)'s Riociguat for Lung Disease 8/7/2013
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
Boehringer Ingelheim Corporation's Gilotrif Wins FDA OK for Advanced Lung Cancer 7/15/2013
GlaxoSmithKline (GSK) Catches Analysts Off-Guard and Files Melanoma Drug Combo Early in Race to Market 7/11/2013
Johnson & Johnson (JNJ), Pharmacyclics, Inc. (PCYC) Submits NDA for Breakthrough Drug Ibrutinib 7/10/2013
FDA Puts Achillion Pharmaceuticals, Inc. (ACHN) Hepatitis C Drug on Clinical Hold 7/3/2013
FDA OKs Hisamitsu Pharmaceutical's First Nonhormonal Drug for Hot Flashes 7/2/2013
FDA Rejects AVEO Oncology (Formerly known as AVEO Pharmaceuticals, Inc.) (AVEO)'s Kidney Cancer Drug, Asks for Additional Trial 6/11/2013
Obama Administration Reverses Course on Teva Pharmaceutical Industries Limited (TEVA)'s Plan B Pill 6/11/2013
Celgene (CELG)'s Revlimid Wins FDA Lymphoma Approval 6/7/2013
Depomed, Inc. (DEPO) Abandons Menopause Drug After FDA Rejection 6/3/2013
FDA Approves Two GlaxoSmithKline (GSK) Melanoma Drugs 5/31/2013
Bayer AG (BAYZF), Algeta Win FDA Approval for Prostate Cancer Drug 5/16/2013
Genentech (RHHBY) Wins New FDA OK for Lung Cancer Drug, Diagnostic Test 5/15/2013
FDA Approves GlaxoSmithKline (GSK)/Theravance, Inc. (THRX) Drug for COPD Lung Disease 5/13/2013
Gilead Sciences, Inc. (GILD) Fails FDA Approval for Two HIV Drugs in 4-in-1 Pill 5/6/2013
FDA Approves Genentech (RHHBY)'s ACTEMRA® for Children Living With a Rare Form of Arthritis 5/1/2013
FDA Panel Backs Approval of GlaxoSmithKline (GSK), Theravance, Inc. (THRX) Lung Drug 4/22/2013
GlaxoSmithKline (GSK)'s Avandia Gets Second Look at Heart Risk by U.S. 4/12/2013
Gilead Sciences, Inc. (GILD) Pushes for FDA Blockbuster Approval 4/11/2013
Johnson & Johnson (JNJ), Pharmacyclics, Inc. (PCYC) Gets New Breakthrough-Therapy Designation for Ibrutinib 4/8/2013
Biogen Idec, Inc. (Massachusetts) (BIIB) Wins FDA Approval for Blockbuster Oral MS Drug 3/28/2013
Novartis AG (NVS) Breast Cancer Drug Rejected Despite Being Hailed as a "Breakthrough" 3/25/2013
FDA Rejects Pharmaxis Ltd (PXS.AX) Drug Push Bid 3/19/2013
Heart Warning Added to Pfizer Inc. (PFE)s "Z-Pak" Antibiotic by FDA 3/13/2013
FDA Panel Rejects Depomed, Inc. (DEPO) Menopause Treatment 3/5/2013
FDA Approves Shionogi, Inc.'s Drug for Painful Intercourse in Women 2/27/2013
FDA Approves Genentech (RHHBY)'s Drug for Late-Stage Metastatic Breast Cancer 2/26/2013
FDA Approves Novartis AG (NVS)'s Zortress to Prevent Liver Transplant Rejection 2/19/2013
FDA Approves Celgene Corporation (CELG)'s Pomalyst for Advanced Multiple Myeloma 2/12/2013
Hemispherx Biopharma (HEB) Says FDA Rejects Fatigue Drug Application 2/5/2013
FDA Panel Backs Boehringer Ingelheim Corporation COPD Drug 1/31/2013
Allergan Inc. (AGN)'s Botox Gets FDA Approval for Overactive Bladder 1/23/2013
NuPathe Inc. (PATH) Shares Jump After FDA Approves Migraine Patch 1/21/2013
Santarus Inc. (SNTS) Wins FDA Approval for Ulcerative Colitis Therapy; Will Add 85 New Sales Reps to Support Drug 1/17/2013
FDA Panel Backs Johnson & Johnson (JNJ)'s Risky Diabetes Drug 1/14/2013
Bristol-Myers Squibb Company (BMY)-Pfizer Inc. (PFE)'s Blood Thinner Eliquis Wins FDA Approval 1/3/2013
Ariad Pharmaceuticals, Inc. (ARIA) Wins FDA Approval for Drug to Treat Rare Leukemias 12/18/2012
Johnson & Johnson (JNJ)'s Zytiga Wins Approval for Early Prostate Cancer Use 12/11/2012
Sanofi Pasteur (SASY.PA)'s Meningococcus Vaccine Menactra Approved for Infants Down to 9 Months 12/3/2012
Exelixis, Inc. (EXEL)'s FDA Approves Cometriq to Treat Rare Type of Thyroid Cancer 12/3/2012
Theravance, Inc. (THRX) Halted; FDA Panel to Review VIBATIV NDA 11/30/2012
Dynavax Technologies Corporation (DVAX) Falls After Vaccine Fails to Win Panel Backing 11/19/2012
FDA Approves Pfizer Inc. (PFE)'s Rheumatoid Arthritis Pill 11/9/2012
Novo Nordisk A/S (NVO) Upbeat on Tresiba Insulin's U.S. Prospects 11/9/2012
FDA Panel Gives Unanimous OK to Novartis AG (NVS)'s Cushing's Drug 11/8/2012
Novo Nordisk A/S (NVO)'s Insulin Tresiba Has Heart Safety Risks, FDA Says 11/6/2012
FDA Approves Teva Pharmaceutical Industries Limited (TEVA) Leukemia Drug 10/30/2012
FDA Approves Eisai Inc. (ESALF.PK) Drug for Epileptic Seizures 10/24/2012
FDA Panel Backs Sanofi (France) (SAN.PA) and Isis Pharmaceuticals, Inc. (ISIS) Drug for Rare Genetic Disorder 10/22/2012
Aegerion Pharmaceuticals, Inc. (AEGR) Soars as FDA Panel Backs Cholesterol Drug 10/19/2012
FDA: ThromboGenics NV (TBGNF) Main Drug Cleared for U.S. Launch 10/18/2012
Johnson & Johnson (JNJ)'s Janssen Biotech Inc. Unit Submits BLA for Anti-TNF)-alpha SIMPONI 9/19/2012
Sanofi (SAN.PA)'s Genzyme (GENZ) Wins FDA Approval for Multiple Sclerosis Pill 9/14/2012
Amarin Corporation PLC (AMRN) Still Awaits FDA OK for Heart Drug 9/11/2012
FDA Approves Pfizer Inc. (PFE)'s Leukemia Drug 9/6/2012
FDA Approves Teva Pharmaceutical Industries Limited (TEVA) Copycat of Amgen (AMGN)'s Neupogen 8/31/2012
FDA Approves Roche (RHHBY)'s Lucentis to Treat Diabetic Macular Edema 8/10/2012
FDA Approves Talon Therapeutics, Inc. (TLON.OB)'s Marqibo to Treat Rare Type of Leukemia 8/10/2012
FDA Approves First Generic Copies of Merck & Co., Inc. (MRK)'s Singulair 8/7/2012
GlaxoSmithKline (GSK) Files Two Melanoma Drugs for U.S., Europe Approvals 8/6/2012
FDA Approves Sanofi (France) (SAN.PA)-Regeneron Pharmaceuticals, Inc. (REGN)'s Zaltrap for Metastatic Colorectal Cancer 8/6/2012
FDA OKs Onyx Pharmaceuticals, Inc. (ONXX)'s Kyprolis for Multiple Myeloma 7/23/2012
FDA Approves Novartis AG (NVS)'s Afinitor for Breast Cancer 7/20/2012
FDA Approves VIVUS, Inc. (VVUS)'s Weight-Loss Pill 7/19/2012
FDA Approves Gilead Sciences, Inc. (GILD)'s Truvada Pill for HIV Prevention 7/17/2012
FDA Approves Arena Pharmaceuticals, Inc. (ARNA) Obesity Drug; First in 13 Years 6/28/2012
Onyx Pharmaceuticals, Inc. (ONXX) Surges on FDA Panel Vote for Blood-Cancer Drug 6/22/2012
Celgene (CELG) Revlimid Growth Plans Stopped Dead 6/21/2012
FDA OKs Roche (RHHBY)'s New Breast Cancer Drug 6/13/2012
FDA Delays Its Decision on Gilead Sciences, Inc. (GILD)'s Anti-HIV Pill 6/11/2012
Merck & Co., Inc. (MRK)/Ariad Pharmaceuticals, Inc. (ARIA) Fails to Win FDA OK for Sarcoma Drug 6/7/2012
FDA Panel Split on Pfizer Inc. (PFE) Rare Disease Drug 5/29/2012
Astellas Pharma Inc. (YPH.BE)/Medivation, Inc. (MDVN) File Prostate Cancer Drug in USA 5/22/2012
Gilead Sciences, Inc. (GILD)' HIV Quad Pill Wins Backing From FDA Advisers 5/15/2012
Arena Pharmaceuticals, Inc. (ARNA) Wins Positive FDA Panel Vote for Obesity Drug 5/14/2012
Medgenics, Inc. Announces First Quarter 2012 Financial Results 5/14/2012
FDA OKs VIVUS, Inc. (VVUS)'s Fast-acting Viagra Rival 5/1/2012
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
Watson Pharmaceuticals, Inc. (WPI) Launches Generic FORTAMET(R) 4/20/2012
VIVUS, Inc. (VVUS) Weight-Loss Drug Qnexa Gets Three-Month Delay for FDA Review 4/11/2012
Astellas Pharma Inc. (ALPMY) Wins FDA Panel Backing for Overactive Bladder Drug 4/6/2012
Talon Therapeutics, Inc. (HNAB)' Marqibo(R) Wins Backing of FDA Advisory Panel 3/23/2012
Shire plc Drops After Pulling US Application for Replagal, Move Gives Sanofi (France) (SAN.PA) a Boost 3/16/2012
FDA Approves Discovery Laboratories (DSCO) Respiratory Drug for Preemies 3/8/2012
Pfizer Inc. (PFE) Pulls Plug on FDA Application for Pristiq 3/2/2012
FDA Approves Aptalis Pharmaceutical Technologies' 2 Drugs for Rare Digestive Disorders 3/2/2012
FDA Panel Backs Forest Laboratories, Inc. (FRX),Almirall COPD Drug 2/27/2012
VIVUS, Inc. (VVUS) Doubles After Winning Panel Backing for First Weight-Loss Pill in 13 Years 2/24/2012
Amgen (AMGN) Fails to Win Panel Backing for Expanded Xgeva Use FDA 2/10/2012
FDA Approves Vertex Pharmaceuticals (MA) (VRTX)'s Cystic Fibrosis Drug 2/1/2012
FDA Approves Genentech (RHHBY)'s Erivedge (Vismodegib) Capsule, the First Medicine for Adults with Advanced Basal Cell Carcinoma 1/31/2012
FDA Rejects AstraZeneca PLC (AZN)'s and Bristol-Myers Squibb Company (BMY)'s Dapagliflozin for Type 2 Diabetes 1/20/2012
FDA Approves BTG plc (BGC.L)'s Drug for Cancer Toxicity 1/19/2012
FDA Approves Gilead Sciences, Inc. (GILD) NDA for Viread in HIV-Infected Children 1/19/2012
Seattle Genetics, Inc. (SGEN) Lymphoma Drug Gets Boxed Warning on Brain Infection Risk 1/18/2012
FDA to Review Pfizer Inc. (PFE) Rheumatoid Arthritis Drug 12/21/2011
FDA Panel Gives Nod to Johnson & Johnson (JNJ) Drug for Anemia 12/12/2011