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Clinical - BLA/NDA/ANDA
Janssen Research & Development Submits New Drug Application To U.S. FDA For Three-Month Paliperidone Palmitate 11/19/2014
Pernix Therapeutics, Inc. (PTX) Submits sNDA For TREXIMET® Use In Adolescent Patients 11/17/2014
Actavis (ACT) Announces FDA Acceptance Of sNDA For SAPHRIS® (asenapine) For The Treatment Of Bipolar I Disorder In Pediatric Patients 11/13/2014
Janssen Pharmaceutical Inc. Release: U.S. FDA Approves Supplemental New Drug Applications For Once-Monthly Long-Acting Therapy INVEGA® SUSTENNA® (Paliperidone Palmitate) For The Treatment Of Schizoaffective Disorder 11/13/2014
FDA And European Medicines Agency Grant Orphan Designation To Xeris Pharmaceuticals ' Soluble Glucagon For Prevention Of Hypoglycemia In Congenital Hyperinsulinism Patients 11/12/2014
FUJIFILM Holdings Corporation (FUJI) Expects Avigan To Be Approved For Ebola By End Of The Year 11/11/2014
Emergent BioSolutions (EBS) Seeks Expanded Biothrax Label; Submits FDA Application For Post-Exposure Prophylaxis 11/10/2014
FDA Accepts Amgen (AMGN)'s Biologics License Application For LDL Cholesterol-Lowering Medication Evolocumab 11/10/2014
Novartis AG (NVS)'s Panobinostat Fails To Win FDA Panel Support 11/7/2014
U.S. Revokes Approval For Ranbaxy Laboratories (RANBAXY.BO) Copies Of AstraZeneca PLC (AZN), Roche (RHHBY) Drugs 11/7/2014
AVANIR Pharmaceuticals (AVNR)'s Migraine Treatment Will Unlikely Win Approval By Scheduled Timeline 11/7/2014
Rockwell Medical (RMTI) Surges As FDA Panel Recommends Triferic In Hemodialysis Patients 11/7/2014
FDA Advisory Committee Recommends Rockwell Medical (RMTI)'s Triferic For Iron Replacement And Maintenance Of Hemoglobin In Hemodialysis Patients 11/7/2014
Repros Therapeutics Inc. (RPRX) Holds Constructive Meeting With FDA Regarding Androxal® NDA Filing 11/7/2014
Novartis AG (NVS) Announces Outcome Of FDA Advisory Committee Meeting For Multiple Myeloma Investigational Compound LBH589 11/7/2014
Despite Restructuring, AEterna Zentaris (AEZS) Plummets On FDA Rejection 11/6/2014
Gilead Sciences, Inc. (GILD) Submits New Drug Application To U.S. Food And Drug Administration For Tenofovir Alafenamide (TAF)-Based Single Tablet Regimen For HIV 11/6/2014
FDA Issues Complete Response Letter For AEterna Zentaris (AEZS)' Macrilen™ NDA In Adult Growth Hormone Deficiency 11/6/2014
Spriaso Announces Filing Of New Drug Application For The First Long Acting Codeine Antitussive With A Popular Antihistamine 11/6/2014
IMPAX Laboratories, Inc. (IPXL) Submits Marketing Authorization Application To EMA For IPX066 (Carbidopa-Levodopa) Extended-Release Capsules 11/6/2014
Glenmark Generics Receives Final ANDA Approval For Omeprazole DR Capsules 11/5/2014
Advaxis, Inc. Submits Investigational New Drug Application For ADXS31-142 (ADXS-PSA) For The Treatment Of Metastatic Castration Resistant Prostate Cancer 11/5/2014
Vertex Pharmaceuticals (MA) (VRTX) Submits Applications In The U.S. And Europe For Approval Of Lumacaftor In Combination With Ivacaftor For People With Cystic Fibrosis Who Have Two Copies Of The F508del Mutation 11/5/2014
Synta Pharmaceuticals (SNTA) Announces FDA’s Oncologic Drugs Advisory Committee To Discuss Pediatric Uses For Ganetespib 11/5/2014
GlaxoSmithKline (GSK) Submits European, U.S. Filings For Mepolizumab 11/5/2014
FDA Panel Review Of Rockwell Medical (RMTI)'s Dialysis Therapy Raises Doubts About Need 11/5/2014
Sanofi Pasteur (SASY.PA) Announces FDA Approval Of Updated Prescribing Information For Fluzone® High-Dose Vaccine For Adults 65 And Older 11/3/2014
Boehringer Ingelheim Pharmaceuticals, Inc. Announces U.S. Filing Acceptance Of New Drug Application For Spiriva® Respimat® (Tiotropium Bromide) Inhalation Spray For The Treatment Of Asthma 11/3/2014
Novo Nordisk A/S (NVO) More Mindful On Timing Of U.S. Tresiba Launch 10/30/2014
TWi Pharmaceuticals, Inc. Receives U.S. FDA Approval On Generic Donepezil Hydrochloride Tablets USP, 23 Mg, Its Fifth ANDA From U.S. FDA 10/30/2014
FDA Staff Recommends Limited Use Of Daiichi Sankyo, Inc. (4568.t)'s Blood Thinner Edoxaban 10/29/2014
Lundbeck Inc. (LUN.CO) Provides Update On New Drug Application For Intravenous Carbamazepine 10/27/2014
Sarepta Therapeutics (SRPT) Tanks As FDA Seeks Further Data On Eteplirsen; Stock Down 32.47% At Market Close (Oct. 27, 2014) 10/27/2014
FDA Postpones Its Final Decision On NPS Pharmaceuticals, Inc. (NPSP)'s Natpara 10/24/2014
Relypsa, Inc. (RLYP) Submits New Drug Application To U.S. FDA Seeking Approval For Patiromer For Oral Suspension To Treat Hyperkalemia 10/22/2014
Synageva BioPharma (GEVA) Starts Rolling Submission Of A Biologics License Application To The FDA For Sebelipase Alfa 10/22/2014
Alkermes plc (ALKS)’ New Drug Application For Aripiprazole Lauroxil For Treatment Of Schizophrenia Accepted For Filing By U.S. FDA 10/22/2014
FDA Panel Unanimously Backs Novartis AG (NVS)' Psoriasis Drug 10/22/2014
Analysts Predict FDA Approval Of Novo Nordisk A/S (NVO)'s Obesity Drug By Year-End 10/21/2014
Auxilium Pharmaceuticals (AUXL) Announces XIAFLEX Now Approved For The Concurrent Treatment Of Up To Two Affected Joints In The Same Hand In Dupuytren's Contracture Patients 10/21/2014
BioSpecifics Technologies Corporation (BSTC) Announces FDA Approval Of sBLA For XIAFLEX® For The Concurrent Treatment Of Two Dupuytren's Contracture Cords 10/21/2014
Matinas BioPharma Submits Investigational New Drug Application For Lead Product Candidate MAT9001 For The Treatment Of Severe Hypertriglyceridemia 10/20/2014
Janssen Research & Development Release: IMBRUVICA® (ibrutinib) Supplemental New Drug Application Submitted To The U.S. FDA For Waldenstrom's Macroglobulinemia 10/20/2014
FDA Accepts For Review A Biologics License Application For Merck & Co. (MRK) And Sanofi Pasteur (SASY.PA)’s Investigational Pediatric Hexavalent Vaccine 10/20/2014
Pharmacyclics, Inc. (PCYC) Files Supplemental New Drug Application For IMBRUVICA® For Waldenstrom's Macroglobulinemia 10/20/2014
Eisai Inc. (ESALF.PK) Announces FDA Acceptance Of Supplemental New Drug Application For Antiepileptic Drug Perampanel As Adjunctive Treatment Of Primary Generalized Tonic-Clonic Seizures 10/20/2014
Repros Therapeutics Inc. (RPRX) Shares Tank On Drug Application Setback 10/17/2014
Novartis AG (NVS) Psoriasis Drug Secukinumab Benefits Outweighs Risk: FDA Staff 10/17/2014
Actavis (ACT) Confirms Generic Quillivant XR® Patent Challenge 10/16/2014
AstraZeneca PLC (AZN) Holds Its Breath As European Regulators Mull Cancer Drug Fate 10/15/2014
FDA Grants Eisai Company, Ltd. (ESALY.PK)'s Investigational Agent Lenvatinib Priority Review Designation For The Treatment Of Advanced Thyroid Cancer 10/15/2014
Alexion Pharmaceuticals Inc. (ALXN) Submits NDA In Japan For Asfotase Alfa As A Treatment For Patients With Hypophosphatasia 10/15/2014
Supernus Pharmaceuticals (SUPN) Announces Paragraph IV ANDA Filing For Trokendi XR(R) 10/14/2014
Pfizer (PFE)'s Palbociclib Granted FDA Priority Review 10/14/2014
ProSensa Holding N.V. (RNA) Begins NDA Submission To The FDA For Exon-Skipping Drug Drisapersen To Treat Duchenne Muscular Dystrophy 10/13/2014
Synthon Pharmaceuticals Announces Filing Of Glatiramer Acetate 40 Mg/Ml ANDA Containing A Paragraph IV Certification 10/9/2014
FDA Needs More Pediatric Data For Resubmission Of ADHD Drug: Shire 10/9/2014
FDA Grants Priority Review For Genentech (RHHBY)’s Lucentis In Diabetic Retinopathy 10/9/2014
ProSensa Holding N.V. (RNA) Begins NDA Submission To The FDA For Exon-Skipping Drug Drisapersen To Treat Duchenne Muscular Dystrophy 10/9/2014
Teva Pharmaceutical Industries Limited (TEVA) Announces Initiation Of New Drug Application And Positive Results From Second Human Abuse Liability Study For CEP-33237 (Hydrocodone Bitartrate) Extended-Release Tablets 10/8/2014
Bristol-Myers Squibb Company (BMY) Withdraws NDA For Asunaprevir 10/8/2014
Zogenix, Inc. (ZGNX) Submits Modified Formulation Of Zohydro® ER With Potential Abuse Deterrent Properties For FDA Review 10/1/2014
Mesoblast Limited (MSB.AX) Partner JCR Pharmaceuticals Files For Marketing Approval Of The First Allogeneic Stem Cell Product In Japan 10/1/2014
Avedro, Inc. Announces Resubmission Of New Drug Application To FDA For Corneal Cross-Linking 9/30/2014
Bristol-Myers Squibb Company (BMY)'s Immunotherapy Drug Opdivo Gets Six Month FDA Review For Melanoma 9/29/2014
FDA Schedules Type B Pre-NDA Meeting With Repros Therapeutics Inc. (RPRX) 9/26/2014
AcelRx Pharmaceuticals (ACRX) Provides Regulatory Update On Zalviso™ 9/26/2014
BioMarin Pharmaceutical Inc. (BMRN) Release: FDA Receives Paragraph IV Notice Letter for KUVAN® (sapropterin dihydrochloride) Tablets 9/25/2014
Amgen (AMGN) Asks FDA For Biologics License For Breakthrough Cancer Drug Blinatumomab 9/24/2014
U.S. FDA Accepts Otsuka Pharmaceutical Co., Ltd. And Lundbeck Inc. (LUN.CO)'s Filing For Review Of Brexpiprazole For The Treatment Of Schizophrenia And As Adjunctive Therapy For The Treatment Of Major Depression 9/24/2014
Gilead Sciences, Inc. (GILD) Submits New Drug Application To Japan’s Pharmaceutical And Medical Devices Agency For Fixed-Dose Combination Of Ledipasvir/Sofosbuvir For Chronic Hepatitis C Genotype 1 Infection 9/24/2014
Minerva Neurosciences, Inc. (NERV) Announces Completion Of FDA Review Of Investigational New Drug Application For MIN-202 And Plans For First U.S.-Based Clinical Trial 9/22/2014
FDA Panel Denies Clarus Therapeutics' Oral Testosterone Drug Rextoro 9/19/2014
Jaguar Animal Health, Inc. Files Eighth Investigational New Animal Drug Application 9/17/2014
Salix Pharmaceuticals, Ltd. (SLXP) Release: UCERIS® (budesonide) 2mg Rectal Foam For The Induction Of Remission Of Mild-To-Moderate Distal Ulcerative Colitis Granted Tentative Approval By FDA 9/16/2014
Vernalis PLC (VNLPY.PK) Release: FDA Accepts Tuzistra™ XR (CCP-01) NDA For Full Review 9/15/2014
Shire Announces FDA Acceptance For Filing With Priority Review Of Supplemental New Drug Application (sNDA) for Vyvanse® (lisdexamfetamine dimesylate) Capsules (CII) For Adults With Binge Eating Disorder 9/15/2014
FDA Panel Recommends Approval Of NPS Pharmaceuticals, Inc. (NPSP)'s Natpara To Treat Hypoparathyroidism 9/15/2014
Novo Nordisk A/S (NVO)'s Liraglutide Safe, Effective For Obesity: FDA Panel 9/12/2014
FDA Staff Review Of NPS Pharmaceuticals, Inc. (NPSP) Drug Natpara Sparks Stock Rebound 9/11/2014
FDA Initial Briefs Find Novo Nordisk A/S (NVO)'s Liraglutide Effective 9/11/2014
NPS Pharmaceuticals, Inc. (NPSP) Release: FDA Posts Briefing Materials For Advisory Committee Meeting Reviewing Natpara® For Hypoparathyroidism 9/10/2014
Actavis (ACT) Blood Pressure Pill Not Backed By FDA Advisers 9/10/2014
Relmada Therapeutics Announces The Filing Of Clinical Trial Application In Canada For d-methadone 9/10/2014
Orexigen Therapeutics, Inc. (OREX), Novo Nordisk A/S (NVO) Seek To Enter Still Struggling Obesity Market This Week 9/9/2014
Tesaro, Inc. (TSRO) Announces Submission Of Rolapitant New Drug Application (NDA) To FDA 9/8/2014
Basilea Pharmaceutica (BSLN.SW)'s Partner Astellas Pharma Inc. (ALPMY) Receives Notification From FDA Of Acceptance Of Filing Of Isavuconazole NDA For The Treatment Of Invasive Aspergillosis And Invasive Mucormycosis 9/8/2014
Astellas Pharma Inc. (ALPMY) Receives Notification From FDA Of Acceptance Of Filing Of Isavuconazole NDA For The Treatment Of Invasive Aspergillosis And Invasive Mucormycosis 9/8/2014
Gilead Sciences, Inc. (GILD) Release: First-Line Combination Of Ambrisentan And Tadalafil Reduces Risk Of Clinical Failure Compared To Monotherapy In Pulmonary Arterial Hypertension Outcomes Study 9/8/2014
Opko Health, Inc. Licensee Tesaro, Inc. (TSRO) Submits New Drug Application for Rolapitant 9/8/2014
Actavis (ACT) Announces FDA Acceptance Of The NDA Filing For Ceftazidime-Avibactam, A Qualified Infectious Disease Product 9/5/2014
FDA Accepts Investigational New Drug Application For ALPHAEON's Neurotoxin EVOSYAL 9/4/2014
Halozyme Therapeutics, Inc. (HALO)'s PEGPH20 Program In Metastatic Pancreatic Cancer Receives Fast Track Designation 9/3/2014
Actavis (ACT) Announces FDA Acceptance For Filing Of NDA For Eluxadoline 9/2/2014
Salix Pharmaceuticals, Ltd. (SLXP) Submits Response To XIFAXAN® 550mg Complete Response Letter Regarding Repeat Treatment For Irritable Bowel Syndrome With Diarrhea 9/2/2014
Ipsen (IPN.PA) Announces Acceptance Of Filings For Somatuline® In The Treatment Of GEP-NET1s In The U.S. With Priority Review And In Europe 9/2/2014
Momenta Pharmaceuticals, Inc. (MNTA) Announces Abbreviated New Drug Application For Three-Times-A-Week Generic Copaxone Accepted For Review By FDA 8/28/2014
Takeda Pharmaceutical Co. Ltd. (TKPYY) Announces Completion Of The Post-Marketing Commitment To Submit Data To The FDA, The European Medicines Agency And The PMDA For Pioglitazone Containing Medicines Including ACTOS 8/28/2014
Mylan Inc. (MYL)'s ANDA For Three Times Per Week Generic Copaxone® 40 Mg/Ml Accepted For Filing By FDA 8/28/2014
ACADIA Pharmaceuticals, Inc. (ACAD) Announces Trade Name NUPLAZID™ For Pimavanserin 8/28/2014
Amgen (AMGN) Submits BLA For Cholesterol Drug Evolocumab 8/28/2014
U.S. Approval Of Merck & Co., Inc. (MRK) Cancer Immunotherapy Expected Soon 8/26/2014
Alkermes plc (ALKS) Submits New Drug Application To FDA For Aripiprazole Lauroxil For Treatment Of Schizophrenia 8/25/2014
Supernus Pharmaceuticals (SUPN) Announces Paragraph IV ANDA Filing for Trokendi XR® 8/21/2014
Aeolus Pharmaceuticals Inc. (AOLS.OB) Files Investigational New Drug Application With U.S FDA To Enable Initiation Of Human Safety Studies For The Development Of AEOL 10150 As A Medical Countermeasure Against Lung Damage From Radiation Exposure 8/20/2014
FDA Tentatively Approves Boehringer Ingelheim Corporation, Eli Lilly and Company (LLY)'s Basaglar™ 8/19/2014
Bioniche Life Sciences Inc. (BNC) Announces Q1/2015 Timeline For The Filing Of A Biologics License Application For Marketing Approval Of MCNA In The United States 8/19/2014
Boehringer Ingelheim Pharmaceuticals, Inc. Announces U.S. Filing For The Fixed-Dose Combination Tiotropium Plus Olodaterol For Patients With COPD 8/19/2014
Pfizer Inc. (PFE) Announces Submission Of Palbociclib New Drug Application To The FDA 8/18/2014
ARCA biopharma Announces Health Canada Acceptance Of Genetic-AF Clinical Trial Application 8/18/2014
Pfizer Inc. (PFE)'s License Application For Meningococcal B Accepted By The FDA 8/15/2014
FDA Continues To Seek More Data On Acura Pharmaceuticals, Inc. (ACUR)'s Abuse-Resistant Pain Drug 8/15/2014
Celltrion, Inc. (068270.KQ) Files For Approval Of Remicade Biosimilar In US 8/13/2014
Kythera Biopharmaceuticals (KYTH) Submits New Drug Submission To Health Canada For ATX-101 As First-In-Class Treatment For The Reduction Of Submental Fat 8/12/2014
BioDelivery Sciences International (BDSI) Announces BEMA Buprenorphine NDA Submission On Track Following Pre-NDA Meeting With FDA 8/12/2014
INSYS Therapeutics Submits NDA For Its New Oral Formulation Of Dronabinol 8/12/2014
Salix Pharmaceuticals, Ltd. (SLXP) Release: FDA Assigns September 29, 2014 Prescription Drug User Fee Act Goal Date For RELISTOR® Subcutaneous Injection Snda For The Treatment Of Opioid-Induced Constipation In Patients With Chronic Non-Cancer Pain 8/11/2014
Genentech (RHHBY) Submits Supplemental Biologics License Application To FDA For Lucentis Indication In Diabetic Retinopathy 8/8/2014
Emergent BioSolutions (EBS) Submits Biologics License Application To FDA For Anthrax Immune Globulin Intravenous (Human) 8/7/2014
Incyte Corporation (INCY) Release: FDA Accepts Supplemental New Drug Application For Jakafi® (Ruxolitinib) And Priority Review Granted 8/5/2014
Benefit Of Baxter International, Inc. (BAX)'s Immune Therapy Outweighs Risk: FDA Panel 8/1/2014
FDA Panel Reviews Safety Of Baxter International, Inc. (BAX)'s Experimental Drug For Immune System Disorders 7/31/2014
Perrigo Company (PRGO) Confirms First To File Patent Challenge For Generic Version Of Topicort® Topical Spray 0.25% 7/30/2014
FDA Rejects Redwood City's AcelRx Pharmaceuticals (ACRX) Painkiller Dispensing Device; Stock Plunges -34.35% At 9:37AM ET 7/29/2014
FDA Accepts For Review Adamis Pharmaceuticals (ADMP)' New Drug Application For Its Epinephrine Pre-Filled Syringe 7/29/2014
Amgen (AMGN) Nervous As FDA Paves Way For Novartis AG (NVS) To Copy Drug Neupogen 7/28/2014
Assembly Biosciences Provides Update On Status Of VEN 307 7/25/2014
Rich Pharmaceuticals Hires Contract Research Organization To File NDA And Identify Clinical Trial Site(S) For Lead Compound 7/23/2014
FDA Grants Genentech (RHHBY)’s Avastin Priority Review For Recurrent Platinum-Resistant Ovarian Cancer 7/23/2014
Medicines360 And Actavis (ACT) Announce FDA Acceptance For Filing Of NDA For Levosert™ IUD 7/21/2014
Medivir AB (MVRBF): FDA Has Granted Priority Review For OLYSIO® In Combination With Sofosbuvir Supplementary New Drug Application 7/15/2014
Teva Pharmaceutical Industries Limited (TEVA) Announces FDA Acceptance Of NDA Filing For Investigational Short-Acting Beta-Agonist (SABA) Inhaler (Albuterol MDPI) 7/14/2014
Actavis (ACT) Confirms Generic Diclegis® Patent Challenge 7/14/2014
Janssen Pharmaceutical Inc. Seeks Expanded Label For Once-Monthly INVEGA® SUSTENNA® (paliperidone palmitate) To Show Delayed Time To Relapse Compared To Daily Oral Schizophrenia Therapies 7/14/2014
Otsuka Pharmaceutical Co., Ltd. And H. Lundbeck A/S (LUN.CO) Submit New Drug Application In The US For Brexpiprazole For The Treatment Of Schizophrenia And As Adjunctive Therapy For The Treatment Of Major Depressive Disorder 7/14/2014
FDA Office Of Drug Evaluation III Approves Salix Pharmaceuticals, Ltd. (SLXP)’s Request That The FDA Approve The RELISTOR® Subcutaneous Injection sNDA For The Treatment Of Opioid-Induced Constipation In Patients With Chronic Non-Cancer Pain 7/14/2014
Progenics Pharmaceuticals, Inc. (PGNX) Holds Conference Call This Morning On FDA Appeal Response Regarding Relistor® sNDA For Patients With Chronic Non-Cancer Pain 7/14/2014
Kythera Biopharmaceuticals (KYTH) Announces FDA Acceptance Of ATX-101 New Drug Application 7/11/2014
Bristol-Myers Squibb Company (BMY) Announces Plans For Third Quarter Submission Of A Biologics License Application For Opdivo® (Nivolumab), An Investigational PD-1 Immune Checkpoint Inhibitor, For Previously Treated Advanced Melanoma 7/10/2014
Astellas Pharma Inc. (ALPMY) Submits U.S. New Drug Application For Isavuconazole For The Treatment Of Invasive Aspergillosis And Invasive Mucormycosis 7/9/2014
Basilea Pharmaceutica (BSLN.SW)'s Partner Astellas Pharma Inc. (ALPMY) Submits Isavuconazole U.S. NDA For The Treatment Of Invasive Aspergillosis And Invasive Mucormycosis 7/9/2014
FDA Accepts Sanofi (France) (SAN.PA)'s New Drug Application For Lantus Successor Toujeo® 7/8/2014
InSite Vision (ISV) Plans To Submit New Drug Application To FDA For Dexasite™ For The Treatment Of Blepharitis In Adults 7/8/2014
Iroko Pharmaceuticals Announces First International Filing for ZORVOLEX® 7/8/2014
INSYS Therapeutics Updates Timing Of NDA For Dronabinol Oral Solution 7/8/2014
Actavis (ACT) Confirms Generic Ampyra® Patent Challenge 7/8/2014
Teva Pharmaceutical Industries Limited (TEVA) Tries Out A New Tactic In Battle For Generic MS Drug 7/7/2014
Eagle Pharmaceuticals (EGRX) Receives Tentative Approval For Patented, Ready-to-Dilute Bendamustine Hydrochloride Injection NDA 7/2/2014
Zogenix, Inc. (ZGNX) Details Timeframe For Possible New Versions Of Zohydro 7/2/2014
U.S. FDA Accepts NDA Filing For Boehringer Ingelheim Corporation's Investigational Nintedanib And Grants Priority Review Designation For The Treatment Of Idiopathic Pulmonary Fibrosis 7/2/2014
Pozen, Inc. (POZN) Resubmits PA8140/PA32540 NDA 7/2/2014
Vertex Pharmaceuticals (MA) (VRTX) Submits Supplemental New Drug Application (sNDA) To FDA For Use Of KALYDECO® (Ivacaftor) In People 18 And Older With Cystic Fibrosis Who Have The R117H Mutation 7/1/2014
Allergan Inc. (AGN) Gets FDA Approval For Orzurdex, Third Rejection For Levadex 7/1/2014
GlaxoSmithKline (GSK) And Theravance, Inc. (THRX) Announce Submission To US Regulatory Authorities For Fluticasone Furoate/Vilanterol In Asthma 6/30/2014
Vernalis PLC (VNLPY.PK) And Tris Pharma, Inc. Release: Submission Of Tuzistra™ XR (CCP-01) NDA To FDA 6/30/2014
Rockwell Medical (RMTI) Announces FDA Approves $2.2 Million Application Fee Refund For Triferic™ NDA 6/30/2014
Cancer Drug Olaparib Setback Tarnishes AstraZeneca PLC (AZN)'s R&D Claims 6/27/2014
Gilead Sciences, Inc. (GILD) Submits New Drug Application To Japan’s Pharmaceutical And Medical Devices Agency For Sofosbuvir For Chronic Hepatitis C 6/27/2014
Acorda Therapeutics (ACOR)' Multiple Sclerosis Drug AMPYRA® Faces Generic Threat 6/26/2014
FDA Staff Challenge Data On AstraZeneca PLC (AZN)'s Ovarian Cancer Drug Olaparib 6/25/2014
Boehringer Ingelheim Corporation Exits Hepatitis C Field, Pulls Regulatory Filings For Faldaprevir 6/24/2014
IGI Laboratories, Inc. Completes Its Seventh Anda Filing For 2014 Under Joint Drug Development And Commercialization Agreement With IMPAX Laboratories, Inc. (IPXL), Inc. 6/20/2014
IGI Laboratories, Inc. Announces 18th and 19th ANDA Submissions 6/20/2014
Cubist Pharmaceuticals, Inc. (CBST) Announces Acceptance Of Ceftolozane/Tazobactam New Drug Application With Priority Review 6/20/2014
IGI Laboratories, Inc. Announces Fourth ANDA Submission In 2014 6/19/2014
Type 2 Diabetes: Boehringer Ingelheim Pharmaceuticals, Inc. And Eli Lilly and Company (LLY) Announce Resubmission Of New Drug Application For Empagliflozin To FDA 6/18/2014
IGI Laboratories, Inc. Announces Sixteenth ANDA Submission 6/18/2014
Chia-Tai Tianqing Files IND For Biotech Product Licensed From Alphamab 6/18/2014
Pfizer Inc. (PFE) Announces Submission Of Biologics License Application To The FDA For Investigational Meningococcal B Vaccine 6/17/2014
Novartis AG (NVS) Submits Application To The FDA For Meningitis B Vaccine Candidate Bexsero® To Help Protect US Adolescents And Young Adults 6/17/2014
FDA Accepts New Drug Application For Symplmed's Prestalia® For The Treatment Of Hypertension 6/17/2014
Flamel Technologies (FLML) Receives Class 1 Response Designation For Second NDA 6/16/2014
Avion Pharmaceuticals, Announces Positive Feedback From The FDA On Two New Drug Applications 6/16/2014
Enanta Pharmaceuticals, Inc. Announces U.S. FDA Grants Priority Review To AbbVie (ABBV) For Investigational, All-Oral, Interferon-Free Regimen For Genotype 1 Chronic Hepatitis C 6/16/2014
Sucampo Pharmaceuticals, Inc. (SCMP) Issues Statement Regarding Anesthetic and Analgesic Drug Products Advisory Committee Meeting's Vote 6/13/2014
Shire Pharmaceuticals Group plc (SHPGY) Agrees To FDA Request To Conduct Clinical Trials Investigating The Potential Use of Vyvanse® (lisdexamfetamine dimesylate) In Preschool-Age Children With ADHD 6/12/2014
Progenics Pharmaceuticals, Inc. (PGNX) Stock Trading Halted Today; FDA Advisory Committee To Consider And Provide Recommendations Regarding Peripherally-Acting Opioid Receptor Antagonists 6/11/2014
Orexigen Therapeutics, Inc. (OREX)'s Contrave: Is This The Weight Loss Drug We've Been Waiting For? 6/10/2014
Orexigen Therapeutics, Inc. (OREX)'s Diet Pill Contrave May Get FDA Approval This Week 6/10/2014
OptiNose AS Presents Positive Results From Phase 3 COMPASS Study 6/10/2014
Rockwell Medical (RMTI) Wins Appeal For Determination As Small Business For New Drug Application Filing For Triferic™ 6/9/2014
Pharmacyclics, Inc. (PCYC) Release: Supplemental New Drug Application For IMBRUVICA® Accepted By The FDA And Priority Review Granted 6/9/2014
Upsher-Smith Laboratories Receives Final NDA Approval For Vogelxo™ (Testosterone) Gel CIII 6/5/2014
Flamel Technologies (FLML) Announces Intent To Resubmit Second NDA 6/5/2014
Hyperion Therapeutics Announces Health Canada Accepts RAVICTI® New Drug Submission With Priority Review 6/3/2014
FDA Gives ProSensa Holding N.V. (RNA)'s Lead Drug Drisapersen A New Path Towards Approval 6/3/2014
IGI Laboratories, Inc. Announces Fifteenth ANDA Submission 6/2/2014
FDA Will Review Genzyme Corporation (GENZ)'s Lemtrada Resubmission; Agency Action Expected In Q4 2014 5/30/2014
Newron Pharmaceuticals (NWRN) Release: Safinamide New Drug Application Submitted To The FDA 5/29/2014
Adamis Pharmaceuticals (ADMP) New Drug Application To FDA For Its Epinephrine Pre-Filled Syringe 5/29/2014
Rockwell Medical (RMTI) Announces FDA Acceptance For Filing Of Triferic™ New Drug Application 5/28/2014
Mallinckrodt Pharmaceuticals (MNK)’ New Drug Application Accepted For Review By FDA 5/28/2014
QRxPharma Ltd. (QRXPY) Receives Complete Response Letter From FDA Regarding Moxduo® NDA 5/27/2014
InterMune, Inc. (ITMN) Announces Resubmission Of NDA For Pirfenidone For The Treatment Of Patients With IPF 5/27/2014
AbbVie (ABBV) Files New Drug Submission To Health Canada For Its Investigational, All-Oral, Interferon-Free Therapy For The Treatment Of Hepatitis C 5/22/2014
Novo Nordisk A/S (NVO): FDA Schedules Advisory Committee Meeting For Liraglutide 3 Mg For The Treatment Of Obesity 5/21/2014
Antibe Therapeutics Inc. Announces Submission Of Clinical Trial Application To Health Canada For ATB-346 5/21/2014
Shire Plans To Submit A New Drug Application To FDA For Lifitegrast For Dry Eye Disease In Adults 5/19/2014
Pfizer Inc. (PFE) Pursues Early Approval For Breast Cancer Drug 5/19/2014
Novartis AG (NVS)'s Heart Drug Rejected By FDA 5/19/2014



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