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Clinical - BLA/NDA/ANDA
Amerigen Pharmaceuticals Announces Tentative Approval Of Generic Bystolic 4/17/2015
AbbVie (ABBV)'s Investigational Chronic Hepatitis C Treatment Granted Priority Review In Japan 4/16/2015
Baxter International (BAX) Submits Application To Japan’s MHLW For Approval Of BAX 855, Extended Half-Life Recombinant FVIII Based On ADVATE For Hemophilia A 4/16/2015
Enanta Pharmaceuticals, Inc. Announces AbbVie (ABBV)’s Investigational Treatment Regimen For Genotype 1 Chronic Hepatitis C Granted Priority Review In Japan 4/16/2015
Teva (TEVA) And Eagle Pharmaceuticals (EGRX) Announce NDA For Bendamustine Rapid Infusion Product Accepted For Filing 4/14/2015
The Medicines Company (MDCO)’s Kengreal Gets FDA Support After Previous Setbacks 4/14/2015
Depomed, Inc. (DEPO) Announces Gralise ANDA Litigation Settlement Confirming Exclusivity To 2024 And Dismissing Appeal 4/13/2015
Gilead (GILD)'s Next-Gen HIV Drug Heads to the FDA, Stock Soars 4/10/2015
Shire (SHPGY) Release: FDA Grants Priority Review To Lifitegrast NDA For The Treatment Of Dry Eye Disease In Adults 4/10/2015
Dr. Reddy's Laboratories Ltd. (RDY) And Its Subsidiary Promius Pharma, LLC Announce The Filing Of Three NDAs With The USFDA 4/8/2015
Gilead (GILD) Submits New Drug Application To U.S.FDA For Fixed-Dose Combination Of Emtricitabine/Tenofovir Alafenamide For HIV Treatment 4/8/2015
Oncolytics Biotech Inc. (ONC.TO) Announces Filing For Orphan Drug Designation With The U.S. FDA For Gastric Cancer 4/7/2015
Actavis (ACT) Confirms Generic Letairis Patent Challenge 4/6/2015
FDA Files Supplemental New Drug Application For Boehringer Ingelheim's Pradaxa (dabigatran etexilate mesylate) For The Prophylaxis Of Deep Venous Thrombosis And Pulmonary Embolism After Hip Replacement Surgery 4/6/2015
Flexion (FLXN) CEO Discusses Pipeline and Jobs 4/3/2015
Repros Therapeutics Inc. (RPRX) Announces Acceptance For Filing Of NDA 4/2/2015
Adamis (ADMP) Plummets More Than 30% After FDA Rejects Its Allergy Shot Application 4/1/2015
Protalex, Inc. (PRTX) Announces FDA Acceptance Of Investigational New Drug Application For PRTX-100 To Treat Immune Thrombocytopenia 3/31/2015
Avedro, Inc. Announces Receipt Of Complete Response Letter From FDA For Corneal Cross-Linking NDA 3/31/2015
Novo Nordisk A/S (NVO) Soars on Plans to Resubmit NDAs of Tresiba and Ryzodeg in U.S. 3/30/2015
Adamis (ADMP) Receives Complete Response Letter From FDA For Its Epinephrine Pre-Filled Syringe NDA 3/30/2015
FDA Grants Amgen (AMGN) Priority Review For Kyprolis (Carfilzomib) Supplemental New Drug Application For The Treatment Of Relapsed Multiple Myeloma 3/30/2015
IGI Laboratories, Inc. Announces First ANDA Submission Of 2015 3/26/2015
Lipocine Inc. (LPCN) Announces Results From Pre-NDA Meeting For LPCN 1021, An Oral Testosterone Product Candidate 3/24/2015
Teikoku Pharma USA Announces New Drug Application To The FDA For Docetaxel Injection Concentrate, Non-Alcohol Formula 3/24/2015
FDA Panel Backs GlaxoSmithKline (GSK), Theravance (THRX)'s Breo for Adults, Not Kids 3/23/2015
Amgen (AMGN) Submits Application For Investigational LDL Cholesterol-Lowering Medication Repatha (evolocumab) In Japan 3/20/2015
Coherus Biosciences Finalizes CHS-1701 BLA Enabling Clinical Program And Initiates Pivotal Pharmacokinetic And Pharmacodynamic Study 3/17/2015
Merck & Co. (MRK) Can't Catch a Break for Sugammadex, Faces Third FDA Rejection 3/17/2015
Merck & Co. (MRK) Provides Regulatory Update On Investigational Medicine Sugammadex Injection 3/16/2015
Acadia (ACAD) Tanks as Key Drug is Delayed, CEO Resigns 3/16/2015
Breckenridge Pharmaceutical, Inc. Announces Paragraph IV ANDA Litigation With Boehringer Ingelheim For Its ANDA Dabigatran Etexilate Mesylate Capsules (Pradaxa) 3/13/2015
Bristol-Myers Squibb (BMY) Announces Acceptance Of New Drug Application For Investigational Daclatasvir For FDA Review For The Treatment Of Hepatitis C Genotype 3 3/13/2015
Iroko Pharmaceuticals Announces Acceptance Of U.S. Filing For Solumatrix Meloxicam In Osteoarthritis Pain 3/12/2015
Acadia (ACAD) Updates Planned Timing Of NUPLAZID NDA Submission 3/12/2015
Lpath, Inc. (LPTN) To Submit Additional Data For Lpathomab Investigational New Drug Application 3/11/2015
Egalet Accelerates Development Of Abuse-Deterrent Morphine Egalet-001 And Plans To File New Drug Application In The Fourth Quarter 3/11/2015
Kythera (KYTH) Announces FDA Advisory Committee Unanimously (17-0) Recommends To Approve ATX-101 (Deoxycholic Acid) Injection To Improve The Appearance Of Moderate To Severe Submental Fullness 3/10/2015
PDS Life Sciences Helps Major Pharma Company Receive The First FDA Acceptance Of A BLA Filing Incorporating SEND Requirements 3/10/2015
United Therapeutics Corporation (UTHR) Receives A Rare Pediatric Disease Priority Review Voucher Following The Approval Of Unituxin For Pediatric High-Risk Neuroblastoma 3/10/2015
Stock Jumps as FDA Staff Backs Kythera (KYTH)'s Double Chin Injection 3/9/2015
Spectrum Pharmaceuticals, Inc. (SPPI) Announces FDA's Acceptance Of NDA Filing For Captisol-Enabled (Propylene Glycol-Free) Melphalan 3/9/2015
FDA Accepts Bayer HealthCare (BAY)s Biologics License Application For Investigational Treatment Option In Hemophilia A 3/4/2015
Shares Fall as the FDA Rejects Pacira (PCRX)'s Application for Expanded Use of Pain Drug 3/3/2015
Hutchison Chi-Med To File For Approval Of Two Cancer Drugs In 2016 3/3/2015
Pacira Pharmaceuticals, Inc. (PCRX) Receives Complete Response Letter From FDA For sNDA Seeking Approval Of EXPAREL Use In Nerve Block To Provide Postsurgical Analgesia 3/2/2015
Shire (SHPGY) Submits Application To The U.S. D&A Pharma For Approval Of Lifitegrast For Treatment Of Dry Eye Disease In Adults 3/2/2015
Boehringer Ingelheim Submits Biologics License Application To FDA For Idarucizumab, Investigational Specific Reversal Agent For Pradaxa (Dabigatran Etexilate Mesylate) 3/2/2015
Cardio3 BioSciences Marks First Important Milestone In Regulatory Path Toward C-Cure Market Registration With Paediatric Investigation Plan Waiver From European Medicines Agency 3/2/2015
Newron Pharmaceuticals (NWRN) Release: Xadago (Safinamide) New Drug Application (NDA) Accepted For Filing By The FDA 3/2/2015
Alexion Pharmaceuticals Inc. (ALXN) Release: FDA Grants Priority Review For Asfotase Alfa As A Treatment For Patients With Hypophosphatasia 3/2/2015
Bristol-Myers Squibb (BMY) Release: U.S. FDA Accepts Biologics Licensing Application For Opdivo (Nivolumab) For The Treatment Of Advancedsquamous Non-Small Cell Lung Cancer 3/2/2015
Otsuka Pharmaceutical Co., Ltd. Release: CHMP Recommends Jinarc (Tolvaptan) For Approval In EU: The First Pharmaceutical Treatment For Autosomal Dominant Polycystic Kidney Disease (Adpkd) 2/27/2015
FDA Advisory Committee Recommends Approval For Avedro, Inc.’S Riboflavin Ophthalmic Solutions With UVA Irradiation For Corneal Collagen Cross-Linking To Treat Progressive Keratoconus And Corneal Ectasia 2/27/2015
Otonomy, Inc. (OTIC) Submits New Drug Application To The FDA For Auripro 2/26/2015
Teva Pharmaceutical Industries (TEVA) Announces FDA Acceptance For Review Of NDA For Its Investigational Twice-Daily Hydrocodone Bitartrate Extended-Release Tablets With Proprietary Abuse Deterrence Technology 2/25/2015
Relmada Therapeutics Announces Filing Of Clinical Trial Application In Canada For Novel Oral Formulations Of Buprenorphine 2/24/2015
FDA Accepts BLA Filing For Synageva BioPharma (GEVA)'s Kanuma (Sebelipase Alfa); Grants Priority Review And Assigns Pdufa Date 2/23/2015
Taiho Oncology Announces TAS-102 New Drug Application For Refractory Metastatic Colorectal Cancer Accepted For Review By FDA 2/23/2015
Replicel Life Sciences Submits Clinical Trial Application For Its Dermatological Product 2/23/2015
Endo Pharmaceuticals (ENDP) And BioDelivery Sciences International (BDSI) Announce Acceptance Of NDA For BELBUCA (Buprenorphine Hcl) Buccal Film For The Management Of Chronic Pain 2/23/2015
Eli Lilly (LLY) Announces Update On Regulatory Submission Timing For Basal Insulin Peglispro 2/23/2015
Genentech (RHHBY)'s Cobimetinib Grabs Priority Review for Advanced Melanoma 2/20/2015
Pfizer (PFE) Release: FDA Accepts Supplemental New Drug Application For Priority Review Of RAPAMUNE® (Sirolimus) For Treatment Of Lymphangioleiomyomatosis (LAM) 2/20/2015
FDA Grants Genentech (RHHBY)’s Cobimetinib Priority Review For Use In Combination With Zelboraf (Vemurafenib) In Advanced Melanoma 2/19/2015
Apotex Inc. Announces FDA Has Accepted For Filing its Biosimilar Application for Filgrastim (Grastofil) 2/18/2015
Novartis AG (NVS)'s Potential Blockbuster Heart Drug Could Get FDA Approval by Summer 2/17/2015
Collegium Pharmaceutical, Inc. Secures FDA Acceptance For Filing Of NDA For XTAMPZA ER (Oxycodone Extended-Release Capsules), An Abuse-Deterrent Analgesic For Chronic Pain 2/17/2015
ALR Technologies Inc. Seeks FDA Approval For Insulin Dose Adjustment Feature For Better Diabetes Management 2/17/2015
Sprout Pharmaceuticals Resubmits Flibanserin New Drug Application For The Treatment Of Hypoactive Sexual Desire Disorder In Premenopausal Women 2/17/2015
Avedro, Inc. Announces Date For FDA Advisory Committee Meeting 2/17/2015
Immune Response BioPharma, Inc. Announces Remune FDA BLA Assignment PDUFA Goal December 22nd 2015 2/16/2015
Novartis AG (NVS) Heart Failure Medicine LCZ696 Granted FDA Priority Review 2/16/2015
Amgen (AMGN)'s Melanoma Drug Talimogene Laherparepvec Lands a Date With the FDA 2/13/2015
Pfizer (PFE) Announces FDA Acceptance For Review Of A New Drug Application For ALO-02 (Oxycodone Hydrochloride And Naltrexone Hydrochloride) 2/13/2015
Horizon Pharma plc.  (HZNP) Submits Investigational New Drug Application For ACTIMMUNE In The Treatment Of Friedreich's Ataxia 2/13/2015
Amgen (AMGN) Announces FDA Advisory Committees To Review Talimogene Laherparepvec For The Treatment Of Patients With Metastatic Melanoma 2/12/2015
Breckenridge Pharmaceutical, Inc. Announces Paragraph IV ANDA Litigation With Sanofi (SAN.PA) For Its ANDA Cabazitaxel Solution; IV (Infusion) (Jevtana) 2/12/2015
AbbVie (ABBV) Submits New Drug Application In Japan For Its Investigational, All-Oral, Treatment For Chronic Hepatitis C 2/12/2015
Sucampo Pharmaceuticals, Inc. (SCMP) Announces Resolution Of Par Pharmaceutical, Inc.'s ANDA For RESCULA 2/12/2015
Enanta Pharmaceuticals, Inc. Announces AbbVie (ABBV) Submits New Drug Application To The Japanese Ministry Of Health, Labour And Welfare For Its Investigational, All-Oral, Treatment For Chronic Hepatitis C 2/12/2015
Theravance, Inc. (THRX) Announces FDA Advisory Committee To Review BREO(R) ELLIPTA(R) (FF/VI) For Asthma 2/11/2015
Inspirion Delivery Technologies Announces FDA Acceptance Of MorphaBond ER (morphine sulfate extended-release) New Drug Application; Its Investigational Abuse-Deterrent, Extended-Release Opioid 2/10/2015
Upsher-Smith Laboratories's Vogelxo (Testosterone) Gel 1% (Tubes and Packets) Receives AB-Rating To Testim From FDA 2/10/2015
Jaguar Animal Health Files Ninth Investigational New Animal Drug Application 2/10/2015
Ligand Pharmaceuticals Inc. (LGND) Partner GlaxoSmithKline (GSK) Announces EU Regulatory Submission Seeking Additional Indication For Revolade® 2/6/2015
FDA Accepts Pfizer (PFE)'s sNDA For Xeljanz 2/5/2015
KYTHERA Biopharmaceuticals, Inc. (KYTH) Submits Drug Application In Australia For Novel Submental Contouring Injectable Drug ATX-101 2/5/2015
UCB To File For China Approval Of Parkinson's Disease Patch 2/5/2015
Actavis (ACT) Announces FDA Acceptance of sNDA To Expand TEFLARO® (ceftaroline fosamil) Labeling 2/4/2015
U.S. FDA Accepts For Review CSL Behring's Biologics License Application For rIX-FP For Hemophilia B Patients 2/4/2015
Janssen Research & Development Release: U.S. FDA Grants Priority Review For YONDELIS® (trabectedin) For The Treatment Of Patients With Advanced Soft Tissue Sarcoma 2/3/2015
Repros Therapeutics Inc. (RPRX) Submits New Drug Application To FDA For Androxal® 2/2/2015
Catalyst Pharmaceuticals (CPRX) Announces Encouraging Pre-NDA Meeting With The FDA For Firdapse™ As A Treatment For Lambert-Eaton Myasthenic Syndrome (LEMS) 2/2/2015
Amgen (AMGN) Submits Applications In The U.S. And Europe For Kyprolis (Carfilzomib) For The Treatment Of Relapsed Multiple Myeloma 1/29/2015
Amgen (AMGN) Submits Applications for Cancer Drug Kyprolis in U.S. and Europe 1/28/2015
BioMarin (BMRN) Rewrites Playbook for How Rare Disease Drugs Are Approved 1/28/2015
Regeneron (REGN)-Sanofi (SAN.PA) Gain Edge On Amgen (AMGN) as Cholesterol Drug Snags FDA Priority Review 1/27/2015
Regeneron (REGN) And Sanofi (SAN.PA) Announce Praluent™ (Alirocumab) Biologics License Application Has Been Accepted For Priority Review By FDA 1/26/2015
Antares Pharma, Inc. (ATRS) Provides Regulatory Update On Sumatriptan Injection USP 1/26/2015
FDA Panel Backs Astellas Pharma Inc. (ALPMY)'s CRESEMBA for Invasive Fungal Infections 1/23/2015
Astellas Pharma Inc. (ALPMY) Announces FDA Anti-Infective Drugs Advisory Committee Recommends Approval Of CRESEMBA® (Isavuconazonium) For Treatment Of Invasive Aspergillosis And Mucormycosis 1/23/2015
KYTHERA Biopharmaceuticals, Inc. (KYTH) Announces Date Of FDA Advisory Committee Review Of ATX-101 For The Treatment Of Submental Fullness 1/23/2015
UCB, Inc. (UCBJF.PK) Announces US And EU Regulatory Filings For The Investigational Antiepileptic Drug brivaracetam 1/21/2015
Premier Biomedical Files Initial FDA Submission For Fibromyalgia Treatment 1/20/2015
FDA Grants Priority Review For Three-Month Paliperidone Palmitate For The Treatment Of Schizophrenia 1/19/2015
Pernix Therapeutics, Inc. (PTX) Announces FDA Acceptance With Priority Review Of Its TREXIMET® sNDA For Use In Adolescent Patients 1/16/2015
Pfizer (PFE)'s New Type of Cancer Drug May Get Early Approval: Analysts 1/14/2015
Evofem, Inc. Announces Pre-NDA Meeting With FDA For Amphora® 1/13/2015
Hospira, Inc. Submits New Biologics License Application To U.S. FDA For Proposed Epoetin Alfa Biosimilar 1/12/2015
BioRestorative Therapies, Inc. Reports Successful Meeting With FDA 1/12/2015
Neos Therapeutics Announces Submission Of A New Drug Application For Its Methylphenidate Extended Release Oral Disintegrating Tablet (XR-ODT) For The Treatment Of ADHD 1/12/2015
Novartis AG (NVS) Announces Robust Phase 3 Results For QVA149 And NVA237 And Submits Regulatory Applications To U.S. FDA 1/8/2015
Vectura Group plc (VEC.L) Release: Submission Of Regulatory Applications To U.S. FDA And Robust Phase 3 Results For QVA149 And NVA237 1/8/2015
FDA Panel Unanimously Backs Novartis AG (NVS)'s Copy of Amgen (AMGN) Drug 1/8/2015
Novartis AG (NVS) Submits Two Lung Drugs for FDA Approval; Analysts Question Decision 1/8/2015
Sunovion Pharmaceuticals Inc. Announces FDA Acceptance For Review Of Supplemental New Drug Application For The Use Of Aptiom® (Eslicarbazepine Acetate) As Monotherapy Treatment For Partial-Onset Seizures 1/7/2015
Actavis (ACT) And Gedeon Richter Ltd. (RIG2.F) Announce FDA Receipt Of NDA Resubmission For Cariprazine 1/6/2015
LEO Pharma Announces New Drug Application Submission of the First Aerosol Foam for Plaque Psoriasis 1/6/2015
Kite Pharma, Inc. (KITE) Granted Orphan Drug Designation In The European Union For KTE-C19, Kite's Lead Anti-CD19 Chimeric Antigen Receptor (CAR) T Cell Therapy 1/6/2015
The FDA’s Breakthrough Therapy Program By the Numbers 1/5/2015
Lion Biotechnologies, Inc. Submits Investigational New Drug Application To Conduct Phase 2 Study In Metastatic Melanoma 1/5/2015
Advaxis, Inc. Submits Investigational New Drug Application To FDA For ADXS-HER2 1/5/2015
Sucampo Pharmaceuticals, Inc. (SCMP) Announces Acceptance Of New Drug Submission For AMITIZA® (Lubiprostone) By Health Canada 12/31/2014
Repros Therapeutics Inc. (RPRX) Updates Androxal® Global Regulatory Status 12/30/2014
Alexion Pharmaceuticals Inc. (ALXN) Completes Rolling BLA Submission To U.S. FDA For Asfotase Alfa As A Treatment For Patients With Hypophosphatasia 12/30/2014
Newron Pharmaceuticals (NWRN) Release: Safinamide New Drug Application (NDA) Re-Submitted To The US FDA 12/29/2014
Ligand Pharmaceuticals Inc. (LGND) Partner Spectrum Pharmaceuticals, Inc. (SPPI) Announces Submission Of New Drug Application For Captisol-Enabled™ Melphalan 12/29/2014
Genentech (RHHBY) Release: FDA Approves Gazyva® (Obinutuzumab) Supplemental Biologics License Application With New Data In Previously Untreated Chronic Lymphocytic Leukemia 12/29/2014
Endo Pharmaceuticals (ENDP) And BioDelivery Sciences International (BDSI) Announce NDA Submission For Buprenorphine Hcl Buccal Film For The Management Of Moderate To Severe Chronic Pain 12/24/2014
IGI Laboratories, Inc. Announces Three Additional ANDA Submissions 12/23/2014
PTC Therapeutics, Inc. (PTCT) Begins Rolling NDA Submission To The FDA For Translarna To Treat Duchenne Muscular Dystrophy 12/23/2014
Taiho Oncology Completes Submission Of TAS-102 New Drug Application To The US FDA For The Treatment Of Refractory Metastatic Colorectal Cancer 12/22/2014
Jaguar Animal Health Initiates Filing Of Its First New Animal Drug Application With FDA 12/22/2014
Ligand Pharmaceuticals Inc. (LGND) Partner GlaxoSmithKline (GSK) Announces US Regulatory Submission Seeking Additional Indication For Promacta® 12/22/2014
Baxter International, Inc. (BAX) Submits Application For U.S. FDA Approval Of BAX111, Investigational Recombinant Treatment For Von Willebrand Disease 12/22/2014
Pozen, Inc. (POZN) Crashes As FDA Rejects Two Forms Of Its Lead Drug Yosprala 12/18/2014
Apotex Inc. Announces FDA Has Accepted For Filing Its Biosimilar Application For Pegfilgrastim 12/17/2014
Pozen, Inc. (POZN)’s YOSPRALA™ Receives Complete Response Letter From The FDA 12/17/2014
Bayer HealthCare (BAY) Submits Biologics License Application For BAY 81-8973 For The Treatment Of Hemophilia A In Adults And Children 12/17/2014
Genentech (RHHBY) Submits NDA For Skin Cancer Med Cobimetinib 12/16/2014
CSL Behring Submits Biologics License Application For FDA Approval Of Recombinant Fusion Protein Linking Coagulation Factor IX With Recombinant Albumin (Rix-FP) For Hemophilia B Patients 12/16/2014
Collegium Pharmaceutical, Inc. Submits New Drug Application For Xtampza™ ER (Oxycodone Extended-Release); Its Abuse-Deterrent, Extended-Release Analgesic For The Treatment Of Chronic Pain 12/15/2014
Relypsa, Inc. (RLYP) Announces FDA Acceptance Of New Drug Application For Patiromer For Oral Suspension To Treat Hyperkalemia 12/15/2014
Genentech (RHHBY) Submits New Drug Application To FDA For Investigational Cobimetinib Used In Combination With Zelboraf (Vemurafenib) In Advanced Melanoma 12/15/2014
FDA Confirms Lipocine Inc. (LPCN)'s Previously-Agreed Clinical Development Plan For LPCN 1021 12/15/2014
Otsuka America Pharmaceutical, Inc. And H. Lundbeck A/S (LUN.CO) Release: U.S. FDA Accepts For Review Supplemental New Drug Application For Deltoid Administration Of Abilify Maintena® (Aripiprazole) Extended-Release Injectable Suspension 12/15/2014
Jazz Pharmaceuticals (JAZZ) Initiates Rolling NDA Submission For Defibrotide For The Treatment Of Severe Hepatic Veno-Occlusive Disease 12/12/2014
Supernus Pharmaceuticals (SUPN) Announces Paragraph IV ANDA Filing for Oxtellar XR® 12/10/2014
Supernus Pharmaceuticals (SUPN) Announces Paragraph IV ANDA Filing for Trokendi XR® 12/9/2014
Aprecia Pharmaceuticals Receives FDA Acceptance For Filing For First Product Using Advanced Zipdose® Technology 12/9/2014
Sunovion Pharmaceuticals Inc. Submits Supplemental New Drug Application Seeking Approval For The Use Of Aptiom® (Eslicarbazepine Acetate) As Monotherapy Treatment For Partial-Onset Seizures 12/5/2014
Puma Biotechnology (PBYI) Sinks On Breast Cancer Drug NDA Delay 12/4/2014
Mylan Inc. (MYL) Receives Tentative FDA Approval For Pediatric Formulations Of abacavir/lamivudine Through Innovative Collaboration With ViiV Healthcare And Clinton Health Access Initiative 12/4/2014
Puma Biotechnology (PBYI) Updates Timeline For Filing New Drug Application 12/3/2014
Baxter International, Inc. (BAX) Submits Application For US FDA Approval Of BAX 855, Extended Half-Life Recombinant FVIII Based On ADVATE For Hemophilia A 12/2/2014
Synageva BioPharma (GEVA) Completes Rolling Submission Of Biologics License Application To The FDA For Sebelipase Alfa And Submits Marketing Authorization Application To European Medicines Agency 12/2/2014
IGI Laboratories, Inc. Announces 8th ANDA Submission Of 2014 12/1/2014
AVANIR Pharmaceuticals (AVNR) Receives Complete Response Letter (CRL) From FDA On AVP-825 NDA 12/1/2014
Regeneron (REGN) Release: EYLEA (aflibercept) Injection Accepted For Priority Review By FDA For Diabetic Retinopathy In Patients With Diabetic Macular Edema 12/1/2014
Momenta Pharmaceuticals, Inc. (MNTA) Announces Acceptance Of A Clinical Trial Application In Europe For M923, A Biosimilar Version Of Humira 12/1/2014
Baxter International, Inc. (BAX) Submits Application For U.S. FDA Approval Of BAX 855, Extended Half-Life Recombinant FVIII Based On ADVATE For Hemophilia A 12/1/2014
Ipsen (IPN.PA) Announces FDA Acceptance Of Filing For Dysport® In The Treatment Of Upper Limb Spasticity In Adult Patients 12/1/2014
Bristol-Myers Squibb Company (BMY) Release: ELIQUIS Approved For Treatment Of Venous Thromboembolic Events (Deep Vein Thrombosis [DVT], Pulmonary Embolism [PE]) And Prevention Of Recurrent DVT And PE 11/26/2014
US Court Refuses Ranbaxy Laboratories (RANBAXY.BO) Appeal To Block ANDA Nod For 2 Drugs 11/26/2014
FDA Requires Additional Data On Bristol-Myers Squibb Company (BMY)' Hep C Daclatasvir 11/26/2014
Janssen Research & Development Submits New Drug Application For YONDELIS (trabectedin) To U.S. FDA For The Treatment Of Patients With Advanced Soft Tissue Sarcoma 11/25/2014
Merck & Co. (MRK) Submits New Drug Application To The Japanese Pharmaceuticals And Medical Devices Agency For Omarigliptin, An Investigational Once-Weekly DPP-4 Inhibitor For Type 2 Diabetes 11/24/2014
IGI Laboratories, Inc. Announces ANDA Submission 11/24/2014
Perrigo Company (PRGO) Confirms First To File Patent Challenge For Generic Version Of Aveed (Testosterone Undecanoate) Injection 11/24/2014
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
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
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
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
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
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



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