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Clinical - BLA/NDA/ANDA
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
Amgen (AMGN) Submits Applications In The U.S. And Europe For Kyprolis (Carfilzomib) For The Treatment Of Relapsed Multiple Myeloma 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
Bayer HealthCare (BAY) Submits Biologics License Application For BAY 81-8973 For The Treatment Of Hemophilia A In Adults And Children 12/17/2014
Pozen, Inc. (POZN)’s YOSPRALA™ Receives Complete Response Letter From The FDA 12/17/2014
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
Genentech (RHHBY) Submits NDA For Skin Cancer Med Cobimetinib 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
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
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
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
FDA Panel Recommends Approval Of NPS Pharmaceuticals, Inc. (NPSP)'s Natpara To Treat Hypoparathyroidism 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
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
Relmada Therapeutics Announces The Filing Of Clinical Trial Application In Canada For d-methadone 9/10/2014
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
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



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