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Clinical - BLA/NDA/ANDA
Merck & Co. (MRK) Submits U.S. New Drug Application For Grazoprevir/Elbasvir, An Investigational Once-Daily, Single Tablet Combination Therapy, For Treatment Of Chronic Hepatitis C Genotypes 1, 4, And 6 Infection 5/29/2015
Your Analyst-Vetted Guide to the Five Blockbuster Drugs the FDA May Approve This Summer 5/28/2015
FDA Seeks More Info Before Approving AMAG Pharmaceuticals, Inc. (AMAG)'s Single-Dose Vial of Makena 5/28/2015
IGI Laboratories, Inc. Announces Third ANDA Submission Of 2015 5/28/2015
Pacira (PCRX) Announces Completion Of End-of-Review Process With FDA Regarding EXPAREL sNDA For Nerve Block 5/28/2015
Synageva BioPharma (GEVA) Submits Kanuma (Sebelipase Alfa) Application For LAL Deficiency In Japan 5/27/2015
ZS Pharma (ZSPH) Submits New Drug Application To FDA For ZS-9 For The Treatment Of Hyperkalemia 5/27/2015
FDA Accepts BPL’s Amended BLA Submission For Coagadex (Coagulation Factor X, Human) 5/27/2015
ViiV Healthcare And CHAI Collaboration Delivers Second Milestone With First Filing With The FDA Of Generic Dolutegravir By Aurobindo Pharma (AUROBINDOP.BO) For The Treatment Of HIV 5/26/2015
Tris Pharma, Inc. Announces The FDA Acceptance Of NDA For Dyanavel XR 5/21/2015
KemPharm Completes Pre-NDA Meeting With FDA For KP201/APAP 5/21/2015
Amgen (AMGN), Sanofi (SAN.PA) in Race to Get European Green light for Anti-Cholesterol Drugs 5/21/2015
Wall Street Cheers As Sarepta (SRPT) Soars 50% Premarket on Muscular Dystrophy Drug Filing 5/21/2015
Sarepta (SRPT) Announces Plans To Submit Rolling NDA For Eteplirsen Following Today’s Pre-NDA Meeting With The FDA 5/20/2015
Eagle Pharmaceuticals (EGRX) Submits NDA For Ready-To-Use Bivalirudin To FDA 5/20/2015
Vertex (VRTX) Soars After Hours as FDA Panel Backs Cystic Fibrosis Drug Orkambi 5/15/2015
SteadyMed (STDY) Reports Recent Developments, Financial Highlights And First Quarter 2015 Financial Results 5/14/2015
Cesca Therapeutics Submits U.S. Pivotal IDE Amendment Application For Late Stage Critical Limb Ischemia (CLI) 5/13/2015
Investors Hold Their Breath as Vertex (VRTX) Defends Newly Branded Cystic Fibrosis Treatment to the FDA 5/12/2015
Pain Therapeutics (PTIE) Announces Update On Drug Portfolio 5/12/2015
Janssen Pharmaceutical Release: U.S. FDA Issues Complete Response Letter To sNDA Seeking To Expand The Label For INVEGA SUSTENNA 5/12/2015
Heart-Stopping Morning Leads to Vertex (VRTX) Rise As FDA News Sees Positives 5/11/2015
SteadyMed (STDY) Submits Application For Orphan Drug Designation For Trevyent For Pulmonary Arterial Hypertension 5/7/2015
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
EyeGate Pharma Receives Positive Guidance From FDA On NDA Filing Requirements Of EGP-437 For The Treatment Of Anterior Uveitis 5/4/2015
Baxter BioScience Corporation (BAX) And Merrimack (MACK) Announce Filing For European Approval Of MM-398, An Investigational Treatment For Post-Gemcitabine Metastatic Pancreatic Cancer 5/4/2015
Analyst Says FDA Panel Lukewarm on Amgen (AMGN) Cancer Drug, As Company Deals With Split Personality 5/1/2015
Amerigen Pharmaceuticals Announces Tentative Approval Of Generic Toviaz 4/30/2015
Prior to FDA Vote, Advisory Committee Cites Study Bias Concerns Over Amgen (AMGN) Cancer Vaccine 4/29/2015
AstraZeneca PLC (AZN) Release: FDA Grants Priority Review For Potential New Indication For BRILINTA 4/29/2015
Amgen (AMGN) To Discuss Details Of The Biologics License Application For Talimogene Laherparepvec For Patients With Metastatic Melanoma 4/29/2015
IGI Laboratories, Inc. Announces Second ANDA Submission Of 2015 4/29/2015
Biogen (BIIB) Release: FDA Accepts Biologics License Application For ZINBRYTA (Daclizumab High-Yield Process) For Treatment Of MS 4/29/2015
Otonomy, Inc. (OTIC) Announces FDA Acceptance of AuriPro New Drug Application 4/28/2015
PharmaEngine, Inc. Announces Merrimack (MACK) Completed MM-398 (PEP02) New Drug Application Submission To U.S. FDA 4/28/2015
Merrimack (MACK) And Baxter BioScience Corporation (BAX) Announce Completion Of New Drug Application Submission To U.S. FDA For MM-398 As A Treatment For Post-Gemcitabine Metastatic Pancreatic Cancer 4/27/2015
BioMarin (BMRN) Completes Rolling NDA Submission To FDA For Drisapersen For Treatment Of Duchenne Muscular Dystrophy Amenable To Exon 51 Skipping 4/27/2015
CureDuchenne Celebrates Submission Of First-Ever New Drug Application For Duchenne Muscular Dystrophy Amenable To Exon 51 Skipping; Cureduchenne Was Early Funder Of Drisapersen’s Development 4/27/2015
Bristol-Myers Squibb (BMY) Receives Positive CHMP Opinion In The European Union For Opdivo (Nivolumab) For The Treatment Of Advanced Melanoma In Both First-Line And Previously Treated Patients 4/24/2015
U.S. FDA Grants Priority Review To AbbVie (ABBV) For Investigational, All-Oral, Interferon-Free Therapy For The Treatment Of Genotype 4 Chronic Hepatitis C 4/24/2015
Enanta Pharmaceuticals, Inc. Announces FDA Grants Priority Review For AbbVie (ABBV)’s Investigational, All-Oral, Interferon-Free Treatment Regimen For Genotype 4 Chronic Hepatitis C Infection 4/23/2015
FDA Grants Priority Review To Boehringer Ingelheim's Biologics License Application For Idarucizumab 4/23/2015
Bayer HealthCare (BAY) Release: FDA Accepts Filing Of BETACONNECT For Relapsing-Remitting Multiple Sclerosis Patients Taking BETASERON (interferon beta-1b) 4/22/2015
Pradaxa Maker Boehringer Ingelheim Pharmaceuticals, Inc. Pursues Pradaxa FDA Approval To Treat DVT And PE 4/21/2015
Seattle Genetics, Inc. (SGEN) Release: FDA Accepts Supplemental BLA And Grants Priority Review For ADCETRIS (Brentuximab Vedotin) In The AETHERA Setting For The Post-Transplant Consolidation Treatment Of Hodgkin Lymphoma Patients At High Risk Of Relapse 4/20/2015
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
Shire (SHPGY) Release: FDA Grants Priority Review To Lifitegrast NDA For The Treatment Of Dry Eye Disease In Adults 4/10/2015
Gilead (GILD)'s Next-Gen HIV Drug Heads to the FDA, Stock Soars 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
Avedro, Inc. Announces Receipt Of Complete Response Letter From FDA For Corneal Cross-Linking NDA 3/31/2015
Protalex, Inc. (PRTX) Announces FDA Acceptance Of Investigational New Drug Application For PRTX-100 To Treat Immune Thrombocytopenia 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



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