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Clinical - BLA/NDA/ANDA
Bristol-Myers Squibb (BMY) Release: FDA Accepts Supplemental Biologics License Application for Opdivo (nivolumab) in Previously Treated Non-Squamous Non-Small Cell Lung Cancer Patients 9/2/2015
Bristol-Myers Squibb (BMY) and AbbVie (ABBV) Release: FDA Accepts For Priority Review The Biologics License Application For Empliciti (Elotuzumab) For The Treatment Of Multiple Myeloma In Patients Who Have Received One Or More Prior Therapies 9/1/2015
Telesta Receives FDA BLA Filing Notification Letter And Priority Review Designation For MCNA(1) 8/31/2015
FDA Grants Priority Review For Intercept Pharma (ICPT)'s Obeticholic Acid For The Treatment Of Primary Biliary Cirrhosis 8/31/2015
Lipocine Inc. (LPCN) Submits New Drug Application To FDA For Its Oral Testosterone Replacement Product Candidate, LPCN 1021 8/31/2015
Sun BioPharma Announces U.S. FDA Grants IND For SBP-101 Pancreas Special Effect First in-Class Compound 8/31/2015
Titan Pharmaceuticals (TTP) Announces Resubmission Of The New Drug Application For Probuphine For The Maintenance Treatment Of Opioid Addiction 8/31/2015
Nine Reasons Why The FDA Is Approving Almost Every NDA 8/27/2015
Sarepta (SRPT) May Gain Approval for Duchenne Drug Sooner Than Feb. 26 Deadline, Says Analyst 8/27/2015
FDA And European Medicines Agency Accept Regulatory Applications For Boehringer Ingelheim's Gilotrif (afatinib) For Treatment Of Advanced Squamous Cell Carcinoma Of The Lung 8/25/2015
Amgen (AMGN) Submits New Drug Application For Novel Intravenous Calcimimetic Etelcalcetide (AMG 416) 8/25/2015
Alkermes (ALKS) Says FDA Will Briefly Delay Action Date for Aristada 8/24/2015
Alkermes (ALKS) Provides Update On FDA Review Of ARISTADA For The Treatment of Schizophrenia 8/24/2015
Price-Point for Amgen (AMGN)'s Anti-Cholesterol Drug Repatha Could be a Sticking Point for Investors 8/24/2015
Allergan (AGN) Release: FDA Accepts BOTOX (onabotulinumtoxinA) Resubmission For The Treatment Of Lower Limb Spasticity In Adults 8/20/2015
Evoke Pharma, Inc. Receives Favorable Response From FDA Regarding Pediatric Study Plan For EVK-001 8/18/2015
Guided Therapeutics Advances LuViva PMA Application With FDA 8/18/2015
FDA Accepts Supplemental Biologics License Application (Sbla) For KEYTRUDA (Pembrolizumab), Merck & Co. (MRK)’s Anti-PD-1 Therapy, For First-Line Treatment Of Advanced Melanoma, And Grants Priority Review 8/18/2015
InSite Vision (ISV) Announces FDA Acceptance Of NDA Filing For BromSite (0.075% bromfenac) 8/18/2015
Chiasma Announces FDA Acceptance For Filing Of New Drug Application For Octreotide Capsules In Acromegaly 8/17/2015
Omeros Corporation (OMER) Announces Plan To File Infringement Suit Against ANDA Filer 8/17/2015
INSYS Therapeutics' Dronabinol Oral Solution NDA Accepted For Filing By FDA 8/17/2015
Tesaro (TSRO) Begins Hiring Spree in Anticipation of Its First Drug Approval Next Month 8/14/2015
FDA Pushes Back Review Date on Bristol-Myers Squibb (BMY)'s Key Melanoma Drug Opdivo 8/14/2015
Bristol-Myers Squibb (BMY) Release: FDA Extends Action Date For Supplemental Biologics License Application For Opdivo (Nivolumab) In Previously Untreated Advanced Melanom 8/13/2015
Allergan (AGN) Confirms Generic Noxafil Patent Challenge 8/12/2015
Bay Area's Avinger Announces Early 510(k) Filing for Pantheris 8/12/2015
Teva (TEVA) Announces FDA Acceptance Of NDA For SD-809 For Treatment In Huntington Disease 8/12/2015
ADMA Biologics, Inc. Reports Second Quarter 2015 Results 8/12/2015
Takeda Pharmaceutical Co. Ltd. (TKPYY) Release: FDA Accepts A Supplemental New Drug Application For Review of Brintellix (vortioxetine) Clinical Trial Data That Assessed Cognitive Function In Patients With Major Depressive Disorder 8/11/2015
Collegium (COLL) Announces FDA Advisory Committee Meeting For Xtampza ER, An Abuse-Deterrent Analgesic For Chronic Pain 8/7/2015
IntelliPharmaCeutics Updates Status Of Tentative Approvals Of Generic Focalin XR 8/5/2015
Marathon Pharmaceuticals, LLC To Begin New Drug Application Process For Deflazacort As A Potential Treatment For Patients With Duchenne Muscular Dystrophy 8/5/2015
Cipher Pharma (DND.TO) Announces Acceptance Of 510(K) Submission For Dermadexin By FDA 8/4/2015
Clovis Oncology (CLVS) Completes U.S. And E.U. Regulatory Submissions For Rociletinib For The Treatment Of Advanced EGFR-Mutant T790M+ Non-Small Cell Lung Cancer 8/3/2015
ADMA Biologics, Inc. Announces Submission Of RI-002 Biologics License Application (BLA) To FDA 7/31/2015
ZS Pharma (ZSPH) Announces FDA Acceptance Of ZS-9 New Drug Application 7/30/2015
Lightlake Therapeutics Inc. (LLTP) Announces Adapt Pharma Limited Submits NDA To FDA For Narcan (naloxone) Nasal Spray 7/30/2015
Neos Therapeutics Resubmits New Drug Application For FDA Review Of Amphetamine Extended-Release Orally Disintegrating Tablets To Treat ADHD 7/30/2015
Allergan (AGN) Confirms Generic Tyvaso Patent Challenge 7/30/2015
FDA Accepts Opko Health (OPK)'s New Drug Application For Rayaldee 7/29/2015
Indivior PLC Announces FDA Acceptance Of Naloxone Nasal Spray New Drug Application With Priority Review 7/29/2015
U.S. FDA Accepts For Review CSL Behring's Biologics License Application For Its Novel Rviii-Singlechain Therapy For Patients With Hemophilia A 7/28/2015
Adapt Pharma Submits NDA To FDA For Narcan (Naloxone) Nasal Spray 7/27/2015
Sunesis Pharmaceuticals, Inc. (SNSS) Announces Regulatory Update 7/24/2015
Janssen Therapeutics Submits Supplemental New Drug Application To U.S. FDA For All-Oral, Once-Daily OLYSIO (Simeprevir) In Combination With Sofosbuvir 7/24/2015
IGI Laboratories, Inc. Announces Sixth ANDA Submission Of 2015 7/24/2015
Boehringer Ingelheim Release: MHRA Review Confirms Benefit/Risk Profile Of Alteplase - The Only Licensed Clot Buster For Acute Ischaemic Stroke 7/24/2015
Medivir (MVRBF) Announces That Janssen Submitted Supplemental New Drug Application To U.S. FDA For OLYSIO (Simeprevir) In Combination With Sofosbuvir 7/24/2015
Amgen (AMGN) Submits Supplemental New Drug Application For Kyprolis (Carfilzomib) In Relapsed Multiple Myeloma 7/23/2015
Eagle Pharmaceuticals (EGRX)’ RTU Bivalirudin NDA Accepted for Filing 7/23/2015
Shire (SHPGY) Receives CHMP Positive Opinion In Europe For INTUNIV (guanfacine hydrochloride extended release) As A Non-Stimulant ADHD Treatment For Children And Adolescents 7/23/2015
Osmotica Pharmaceutical Announces Its Second Late Stage NDA Asset, OS-320 (“Osmolex ER”), Has Been Awarded Orphan Drug Status By The United States FDA 7/22/2015
Cardiome Pharma Corp. (COM.TO) Submits Supplemental New Drug Submission (sNDS) For AGGRASTAT To Health Canada 7/22/2015
Catalyst Pharmaceuticals (CPRX) Initiates Rolling NDA Submission For Firdapse For The Treatment Of Lambert-Eaton Myasthenic Syndrome (LEMS) 7/22/2015
Investors Gear Up For Exciting News as FDA Sets Dates for BioMarin (BMRN) and Sarepta (SRPT) DMD Drugs 7/21/2015
Heron (HRTX) Resubmits SUSTOL New Drug Application To FDA 7/20/2015
Rapamycin Holdings Opens Investigational New Animal Drug Application With The FDA Center For Veterinary Medicine 7/16/2015
Allergan (AGN) Notes Receipt Of Paragraph IV Notification On Restasis 7/16/2015
Scioderm To Submit Rolling NDA To U.S. FDA For Zorblisa 7/14/2015
Viking Therapeutics (VKTX) Submits Investigational New Drug (IND) Application For VK5211, A Selective Androgen Receptor Modulator (SARM), In Acute Hip Fracture 7/14/2015
Takeda (TKPYY) Submits New Drug Application For Ixazomib For Patients With Relapsed/Refractory Multiple Myeloma 7/14/2015
Investors Hold Their Breath for Amgen (AMGN)'s D-Day of 2015 7/14/2015
Aquila Solutions, LLC Partners With Evofem, Inc. To Submit New Drug Application To U.S. FDA For Amphora As A Contraceptive 7/13/2015
Eli Lilly (LLY) Gets FDA Panel Nod for Lung Cancer Drug, Despite Earlier Concerns 7/10/2015
Eli Lilly (LLY) Statement On FDA Advisory Committee Review Of Necitumumab 7/10/2015
Genmab A/S (GEN.CO) Announces Completion Of Rolling Submission Of Biologics License Application For Daratumumab In Multiple Myeloma And Achievement Of A USD 15 Million Milestone 7/10/2015
EXCLUSIVE: Ironwood (IRWD), AstraZeneca PLC (AZN) IBS-C Drug Will File in China Next Year, CEO Tells BioSpace (DHX) 7/9/2015
IntelliPharmaCeutics Updates Status Of Tentative Approvals Of Generic Focalin XR 7/9/2015
Amedica Corporation Provides Update On FDA Questions And Femoral Head Testing Protocol Feedback 7/8/2015
FDA Expresses Concerns of Blood Clots Over Eli Lilly (LLY)’s Lung Cancer Drug, Will Discuss Tomorrow 7/8/2015
Gilead (GILD) Bets $125 Million on Spurring Investigational HIV Drug to Market 7/7/2015
Genmab A/S (GEN.CO) Announces European Regulatory Submission For Ofatumumab As Maintenance Therapy For Relapsed CLL 7/7/2015
Evofem Submits New Drug Application To U.S. FDA For Amphora As A Contraceptive 7/6/2015
Breckenridge Pharmaceutical, Inc. Announces Final ANDA Approval For Desvenlafaxine XR Tablets (Pristiq) 7/2/2015
Gilead (GILD) Submits New Drug Application To U.S. FDA For Single Tablet Regimen For HIV Containing Rilpivirine, Emtricitabine And Tenofovir Alafenamide (R/F/TAF) 7/2/2015
Clovis Oncology (CLVS) Initiates Rolling NDA Submission To The FDA For Rociletinib In The Treatment Of Advanced EGFR-Mutant Non-Small Cell Lung Cancer 7/2/2015
Vertex (VRTX) Poised to Become Profitable Following Expected FDA Approval of Orkambi 7/1/2015
IGI Laboratories, Inc. Announces Fifth ANDA Submission Of 2015 7/1/2015
Exelixis (EXEL) Provides Update On Genentech (RHHBY)’s Pending New Drug Application For Cobimetinib, An Exelixis-Discovered Compound 7/1/2015
New Sarepta (SRPT) CEO's Strategy Bears Fruit With NDA Filing 6/30/2015
Telesta Therapeutics Submits Biologics License Application (BLA) To The U.S. FDA 6/30/2015
Intercept Pharma (ICPT) Submits Applications In The U.S. And Europe For Marketing Approval Of Obeticholic Acid For The Treatment Of Primary Biliary Cirrhosis 6/30/2015
BioMarin (BMRN) Announces FDA Accepts Drisapersen NDA For Treatment Of Duchenne Muscular Dystrophy Amenable To Exon 51 Skipping 6/29/2015
CureDuchenne’s Funding Bears Fruit With Drisapersen: First-Ever New Drug Application (NDA) Accepted By FDA For Duchenne Muscular Dystrophy 6/29/2015
Sarepta (SRPT) Completes NDA Submission To FDA For Eteplirsen For The Treatment Of Duchenne Muscular Dystrophy Amenable To Exon 51 Skipping 6/29/2015
PharmaEngine, Inc. Release: MM-398 Receiving The Priority Review Designation By US FDA For New Drug Application And The Acceptance Of Market Authorization Application By EMA In Post-Gemcitabine Metastatic Pancreatic Cancer 6/26/2015
Merrimack (MACK) Release: U.S. FDA Grants Priority Review For MM-398 New Drug Application 6/25/2015
ARK Animal Health, A Subsidiary Of Sorrento, Announces Receipt Of MUMS Drug Designation In Dogs 6/24/2015
Valeant (VRX) and Progenics Pharmaceuticals, Inc. (PGNX) Announce the Submission of U.S. New Drug Application for Oral RELISTOR 6/23/2015
IntelliPharmaCeutics Updates Status Of Tentative Approvals Of Generic Focalin XR 6/19/2015
Hemostemix Prepares Investigational New Drug Application For Review By FDA For Company's Acp-01 Formulation To Treat Critical Limb Ischemia 6/18/2015
TONIX Pharmaceuticals, Inc. (TNXP) Announces Conditional Acceptance Of Tonmya As Proposed Brand Name For Cyclobenzaprine Hcl Sublingual Tablets, 2.8 Mg 6/17/2015
Richter And Allergan (AGN) Announce FDA Has Extended The Review Period For Cariprazine To September 2015 6/16/2015
United Therapeutics Corporation (UTHR) Receives Paragraph IV Notice Letter For Tyvaso 6/15/2015
Teva (TEVA) Announces FDA Acceptance Of The Biologics License Application For Reslizumab 6/15/2015
Chiasma Submits New Drug Application To U.S. FDA For Octreotide Capsules In Acromegaly 6/15/2015
FDA Panel Backs Amgen (AMGN)'s Repatha, But With Strings Attached 6/15/2015
GlaxoSmithKline (GSK) Wins FDA Backing for New Asthma Drug 6/12/2015
InSite Vision (ISV) Announces Completion Of The New Drug Application Submission To The U.S. FDA For Bromsite 6/11/2015
FDA Advisors Back Regeneron (REGN), Sanofi (SAN.PA)'s New Heart Drug With Limits 6/11/2015
Amgen (AMGN) To Discuss Details Of Repatha (Evolocumab) Biologics License Application For The Treatment Of High Cholesterol 6/10/2015
FDA Advisory Committee Recommends Approval Of Regeneron (REGN) And Regeneron (REGN)'s Praluent (Alirocumab) Injection For Patients With Hypercholesterolemia 6/10/2015
Vericel (ASTM) Announces Plan To Submit Biologics License Application To FDA By Year-End 2015 For MACI For The Treatment Of Cartilage Defects In The Knee 6/10/2015
FDA Staff Says Regeneron (REGN), Sanofi (SAN.PA) Drug Cuts Cholesterol But Questions Benefits 6/9/2015
IGI Laboratories, Inc. Announces Fourth ANDA Submission Of 2015 6/9/2015
Repros Therapeutics Inc. (RPRX) Announces Date Of FDA Advisory Committee Review Of NDA 6/9/2015
Genmab A/S (GEN.CO) Announces Start Of Rolling Submission Of Biologics License Application For Daratumumab For Double Refractory Multiple Myeloma To The FDA 6/8/2015
FDA Panel Backs Sprout Pharmaceuticals's Female Viagra 6/5/2015
Janssen Initiates Rolling Submission Of Biologic License Application (BLA) For Daratumumab With U.S. FDA For The Treatment Of Multiple Myeloma 6/5/2015
CASI Pharmaceuticals  (CASI) Files New Drug Clinical Trial Application With China FDATo Expand U.S. Development Of ENMD-2076 In Fibrolamellar Carcinoma 6/4/2015
Lightlake Therapeutics Inc. (LLTP) Announces Adapt Pharma Limited Commences Rolling NDA Submission To The FDA For Intranasal Naloxone 6/3/2015
FDA Accepts Supplemental Biologics License Application (sBLA) For KEYTRUDA (Pembrolizumab), Merck & Co. (MRK)’s Anti-PD-1 Therapy, In Advanced Non-Small Cell Lung Cancer, And Grants Priority Review 6/2/2015
INSYS Therapeutics Submits NDA For Dronabinol Oral Solution 6/2/2015
PharmaEngine, Inc. Announces Filing New Drug Application (NDA) Of MM-398 (PEP02) To Taiwan FDA As A Treatment For Post-Gemcitabine Metastatic Pancreatic Cancer 6/1/2015
Elusys Therapeutics, Inc. Release: U.S. FDA Accepts Biologics License Application For Anthim (Obiltoxaximab) 6/1/2015
Bristol-Myers Squibb (BMY) Release: FDA Accepts Supplemental Biologics License Application For Opdivo+Yervoy Regimen In Patients With Previously Untreated Advanced Melanoma 6/1/2015
Opko Health (OPK) Announces Submission of Rayaldee New Drug Application To FDA 6/1/2015
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
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
Amgen (AMGN)’s T-Vec Cancer Therapy Gets FDA Panel OK 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



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