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BioPharm Executive - Rockville Files
FDA Questions Study Findings, Practicality of Novo Nordisk A/S (NVO)'s Diabetes Drug Ideglira 5/23/2016
Genentech (RHHBY) Nabs FDA Approval of First New Bladder Cancer Drug in 30 Years 5/20/2016
Chiasma Chief Says Firm May Challenge FDA Over Rare-Disease Drug Rejection 5/12/2016
Betting Intensifies Over Sarepta (SRPT)’s DMD Drug 5/6/2016
FDA Clears Acadia (ACAD)'s NUPLAZID, the First Drug for Psychosis Linked to Parkinson's 5/2/2016
Sarepta (SRPT) Craters as the FDA Releases Documents Ahead of Monday’s DMD Drug Hearing 4/22/2016
Chiasma Crashes on FDA Drug Rejection of Mycapssa 4/18/2016
FDA Green Lights AbbVie (ABBV), Genentech (RHHBY)'s New Chronic Lymphocytic Leukemia Drug Venclexta 4/12/2016
FDA Panel Unanimously Backs Speedy Approval of Intercept Pharma (ICPT)'s Liver Disease Drug Ocaliva 4/11/2016 Approves Celltrion (068270.KQ)’s INFLECTRA, the First Cheaper Version of Johnson & Johnson (JNJ) Blockbuster Remicade 4/7/2016
FDA Staff Says Acadia (ACAD)'s Drug for Parkinson's Disease Psychosis Nuplazid is Effective 3/28/2016
Eli Lilly (LLY) Wins FDA Approval for Psoriasis Drug Taltz 3/23/2016
Teva (TEVA) Announces FDA Approval Of CINQAIR (Reslizumab) Injection 3/23/2016
36 DMD Experts Send Letter to the FDA Urging Approval of Sarepta (SRPT)’s Drug 3/22/2016
Elusys Therapeutics, Inc. Receives FDA Approval For ANTHIM (obiltoxaximab) Injection For The Treatment And Prophylaxis Of Inhalational Anthrax 3/21/2016
AstraZeneca PLC (AZN) Continues Its Immuno-Oncology Roll, Durvalumab Gets Breathrough Designation for Bladder Cancer 2/18/2016
Roche (RHHBY)'s Multiple Sclerosis Drug Gets Breakthrough Status, Likely to Haunt Biogen (BIIB) 2/18/2016
FDA Delays Decision on Sarepta (SRPT)'s Muscle-Wasting Disorder Drug 2/9/2016
FDA Spurns Vertex (VRTX) Application for Expanded Use of Kalydeco 2/5/2016
Market Just Got More Crowded as Merck & Co. (MRK)'s New Hepatitis C Drug Wins FDA Approval 1/29/2016
FDA Grants Full Approval for Amgen (AMGN)'s Blood Cancer Drug 1/25/2016
AbbVie (ABBV) and Roche (RHHBY)'s Venetoclax Snags Breakthrough Tag from the FDA for Blood Cancer 1/20/2016
Novartis AG (NVS) Wins Two New FDA Approvals for Cosentyx 1/19/2016
FDA Rejects BioMarin (BMRN)'s Much-Anticipated DMD Drug 1/15/2016
Rhythm Wins FDA Breakthrough Tag for Setmelanotide for the Treatment Of POMC Deficiency Obesity 1/7/2016
Genentech (RHHBY) Wins Accelerated Approval for Alecensa to Treat Specific Lung Cancer Patients 12/14/2015
Alexion (ALXN) Release: FDA Approves Kanuma (Sebelipase Alfa) For The Treatment Of Patients With Lysosomal Acid Lipase Deficiency (LAL-D) 12/8/2015
Kite Pharma (KITE) Surges as FDA Grants Breakthrough Tag for Lymphoma Drug 12/7/2015
Bristol-Myers Squibb (BMY) And AbbVie (ABBV) Receive FDA Approval Of Empliciti (Elotuzumab) For The Treatment Of Patients With Multiple Myeloma Who Have Received One To Three Prior Therapies 12/1/2015
Eli Lilly (LLY)'s New Cancer Drug Portrazza Wins FDA Approval 11/25/2015
Genmab A/S (GEN.CO) Announces FDA Approval Of DARZALEX (Daratumumab) For Multiple Myeloma And Updates Financial Guidance 11/17/2015
Tagrisso (Osimertinib) Approved For Advanced Lung Cancer, Available Immediately At Biologics, Inc. (NC) 11/17/2015
FDA Green Lights Genentech (RHHBY)'s Vemurafenib/Cobimetinib Combo for Melanoma 11/10/2015
FDA Green Lights GlaxoSmithKline (GSK)'s Nucala for Severe Asthma 11/5/2015
Investors Elated as Amgen (AMGN) Wins FDA Approval for First-of-Its-Kind Cancer Killing Virus Drug 10/30/2015
FDA Green Lights Alexion (ALXN)'s Metabolic Disorder Drug Strensiq 10/26/2015
FDA Designates Pfizer (PFE)’s Acute Lymphoblastic Leukemia Drug Breakthrough Status 10/21/2015
FDA Green Lights Boehringer Ingelheim's Blood Thinner Reversal Agent Praxbind 10/19/2015
Eli Lilly (LLY) Gains FDA Breakthrough Therapy Designation for Abemaciclib 10/9/2015
FDA Green Lights Alkermes (ALKS)' Schizophrenia Treatment Aristada 10/7/2015
Taiho Oncology Announces FDA Approval Of LONSURF (Trifluridine And Tipiracil) For Refractory Metastatic Colorectal Cancer (mCRC) 9/23/2015
FDA Approves Allergan (AGN) and Gedeon Richter (RIG2.F)'s Antipsychotic Vraylar 9/18/2015
Genentech (RHHBY)’s Hemophilia A Drug Gets Breakthrough Designation in Potential $11 Billion Market 9/10/2015
Wellstat Therapeutics Corporation Announces FDA Approval Of XURIDEN To Treat Rare Pediatric Disorder Hereditary Orotic Aciduria (HOA) 9/8/2015
Tesaro (TSRO) Wins FDA Nod for Chemotherapy-Induced Nausea Drug Varubi 9/2/2015
Revitalized Exelixis (EXEL) Grabs Breakthrough Tag for Cabozantinib 8/25/2015
Sprout's First-Ever Female Libido Drug Comes With Boxed Warning and Controversy 8/20/2015
Orexo AB (ORXOF) Wins FDA Approval for ZUBSOLV 8/11/2015
FDA Green Lights First 3D Printed Drug From Aprecia 8/6/2015
Hoya Corporation Reports First Quarter Financial Results 7/29/2015
FDA Approves Novartis AG (NVS) Drug Odomzo (sonidegib) For Locally Advanced Basal Cell Carcinoma (laBCC), A Form Of Skin Cancer 7/24/2015
FDA Approves Cholesterol Drug Praluent From Regeneron (REGN), Sanofi (SNY) 7/24/2015
Amgen (AMGN) Release: FDA Approves Kyprolis (carfilzomib) For Combination Use In The Treatment Of Patients With Relapsed Multiple Myeloma 7/24/2015
Otsuka Pharma, H. Lundbeck A/S (LUN.CO) Beat Competitors With FDA Approval of Schizophrenia Drug 7/13/2015
Novartis AG (NVS) Wins Early Approval for Heart Drug Ernesto, Cuts Death Risk by 20% 7/9/2015
Vertex (VRTX) Gets FDA Approval for $259K Per Year CF Drug 7/7/2015
FDA Panel Backs Amgen (AMGN)'s Repatha, But With Strings Attached 6/15/2015
Genentech (RHHBY) Wins Breakthrough Nod From FDA for Systemic Sclerosis Treatment 6/11/2015
FDA Advisors Back Regeneron (REGN), Sanofi (SNY)'s New Heart Drug With Limits 6/11/2015
FDA Grants Breakthrough Designation to Genzyme (GENZ)’s Experimental ASMD Treatment 6/8/2015
Actavis (ACT), Valeant (VRX) Win FDA Approval for VIBERZI to Treat IBS With Diarrhea 5/28/2015
Heart-Stopping Morning Leads to Vertex (VRTX) Rise As FDA News Sees Positives 5/11/2015
AbbVie (ABBV), Genentech (RHHBY) Leukemia Drug Wins Breakthrough Status Tag 5/11/2015
AcelRx (ACRX) Crashes as the FDA Rejects Request for Meeting on Pain Drug Device 5/6/2015
Amgen (AMGN)’s T-Vec Cancer Therapy Gets FDA Panel OK 5/4/2015
Kythera (KYTH) Grabs FDA Approval for Chin Fat-Busting Drug 5/4/2015
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 (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
23andMe Wins FDA Approval for First Genetic Test Kit 2/26/2015
Actavis (ACT) Receives U.S. FDA Approval For AVYCAZ (CEFTAZIDIME-AVIBACTAM) 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
InterMune, Inc. (ITMN) Wins FDA Approval For Lung Drug At Center Of Roche (RHHBY) Deal 10/17/2014
Boehringer Ingelheim Corporation Wins FDA Approval For Lung Disease Drug Ofev 10/17/2014
FDA Approves Gilead (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 (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
QRxPharma Ltd. (QRXPY) Fails To Win Panel Backing For New Painkiller Moxduo 4/23/2014
FDA Approves Eli Lilly and Company (LLY)'s Cyramza For Stomach Cancer 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