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Clinical - BLA/NDA/ANDA
Amgen (AMGN) Nervous As FDA Paves Way For Novartis AG (NVS) To Copy Drug Neupogen 7/24/2014
FDA Grants Genentech (RHHBY)’s Avastin Priority Review For Recurrent Platinum-Resistant Ovarian Cancer 7/23/2014
Rich Pharmaceuticals Hires Contract Research Organization To File NDA And Identify Clinical Trial Site(S) For Lead Compound 7/23/2014
Medicines360 And Actavis (ACT) Announce FDA Acceptance For Filing Of NDA For Levosert™ IUD 7/21/2014
Medivir AB (MVRBF): FDA Has Granted Priority Review For OLYSIO® In Combination With Sofosbuvir Supplementary New Drug Application 7/15/2014
Teva Pharmaceutical Industries Limited (TEVA) Announces FDA Acceptance Of NDA Filing For Investigational Short-Acting Beta-Agonist (SABA) Inhaler (Albuterol MDPI) 7/14/2014
Actavis (ACT) Confirms Generic Diclegis® Patent Challenge 7/14/2014
Janssen Pharmaceutical Inc. Seeks Expanded Label For Once-Monthly INVEGA® SUSTENNA® (paliperidone palmitate) To Show Delayed Time To Relapse Compared To Daily Oral Schizophrenia Therapies 7/14/2014
Otsuka Pharmaceutical Co., Ltd. And H. Lundbeck A/S (LUN.CO) Submit New Drug Application In The US For Brexpiprazole For The Treatment Of Schizophrenia And As Adjunctive Therapy For The Treatment Of Major Depressive Disorder 7/14/2014
FDA Office Of Drug Evaluation III Approves Salix Pharmaceuticals, Ltd. (SLXP)’s Request That The FDA Approve The RELISTOR® Subcutaneous Injection sNDA For The Treatment Of Opioid-Induced Constipation In Patients With Chronic Non-Cancer Pain 7/14/2014
Progenics Pharmaceuticals, Inc. (PGNX) Holds Conference Call This Morning On FDA Appeal Response Regarding Relistor® sNDA For Patients With Chronic Non-Cancer Pain 7/14/2014
Kythera Biopharmaceuticals (KYTH) Announces FDA Acceptance Of ATX-101 New Drug Application 7/11/2014
Bristol-Myers Squibb Company (BMY) Announces Plans For Third Quarter Submission Of A Biologics License Application For Opdivo® (Nivolumab), An Investigational PD-1 Immune Checkpoint Inhibitor, For Previously Treated Advanced Melanoma 7/10/2014
Basilea Pharmaceutica (BSLN.SW)'s Partner Astellas Pharma Inc. (ALPMY) Submits Isavuconazole U.S. NDA For The Treatment Of Invasive Aspergillosis And Invasive Mucormycosis 7/9/2014
Astellas Pharma Inc. (ALPMY) Submits U.S. New Drug Application For Isavuconazole For The Treatment Of Invasive Aspergillosis And Invasive Mucormycosis 7/9/2014
FDA Accepts Sanofi (France) (SAN.PA)'s New Drug Application For Lantus Successor Toujeo® 7/8/2014
INSYS Therapeutics Updates Timing Of NDA For Dronabinol Oral Solution 7/8/2014
Actavis (ACT) Confirms Generic Ampyra® Patent Challenge 7/8/2014
InSite Vision (ISV) Plans To Submit New Drug Application To FDA For Dexasite™ For The Treatment Of Blepharitis In Adults 7/8/2014
Iroko Pharmaceuticals Announces First International Filing for ZORVOLEX® 7/8/2014
Teva Pharmaceutical Industries Limited (TEVA) Tries Out A New Tactic In Battle For Generic MS Drug 7/7/2014
Eagle Pharmaceuticals (EGRX) Receives Tentative Approval For Patented, Ready-to-Dilute Bendamustine Hydrochloride Injection NDA 7/2/2014
Zogenix, Inc. (ZGNX) Details Timeframe For Possible New Versions Of Zohydro 7/2/2014
U.S. FDA Accepts NDA Filing For Boehringer Ingelheim Corporation's Investigational Nintedanib And Grants Priority Review Designation For The Treatment Of Idiopathic Pulmonary Fibrosis 7/2/2014
Pozen, Inc. (POZN) Resubmits PA8140/PA32540 NDA 7/2/2014
Vertex Pharmaceuticals (MA) (VRTX) Submits Supplemental New Drug Application (sNDA) To FDA For Use Of KALYDECO® (Ivacaftor) In People 18 And Older With Cystic Fibrosis Who Have The R117H Mutation 7/1/2014
Allergan Inc. (AGN) Gets FDA Approval For Orzurdex, Third Rejection For Levadex 7/1/2014
Rockwell Medical (RMTI) Announces FDA Approves $2.2 Million Application Fee Refund For Triferic™ NDA 6/30/2014
GlaxoSmithKline (GSK) And Theravance, Inc. (THRX) Announce Submission To US Regulatory Authorities For Fluticasone Furoate/Vilanterol In Asthma 6/30/2014
Vernalis PLC (VNLPY.PK) And Tris Pharma, Inc. Release: Submission Of Tuzistra™ XR (CCP-01) NDA To FDA 6/30/2014
Cancer Drug Olaparib Setback Tarnishes AstraZeneca PLC (AZN)'s R&D Claims 6/27/2014
Gilead Sciences, Inc. (GILD) Submits New Drug Application To Japan’s Pharmaceutical And Medical Devices Agency For Sofosbuvir For Chronic Hepatitis C 6/27/2014
Acorda Therapeutics (ACOR)' Multiple Sclerosis Drug AMPYRA® Faces Generic Threat 6/26/2014
FDA Staff Challenge Data On AstraZeneca PLC (AZN)'s Ovarian Cancer Drug Olaparib 6/25/2014
Boehringer Ingelheim Corporation Exits Hepatitis C Field, Pulls Regulatory Filings For Faldaprevir 6/24/2014
IGI Laboratories, Inc. Completes Its Seventh Anda Filing For 2014 Under Joint Drug Development And Commercialization Agreement With IMPAX Laboratories, Inc. (IPXL), Inc. 6/20/2014
IGI Laboratories, Inc. Announces 18th and 19th ANDA Submissions 6/20/2014
Cubist Pharmaceuticals, Inc. (CBST) Announces Acceptance Of Ceftolozane/Tazobactam New Drug Application With Priority Review 6/20/2014
IGI Laboratories, Inc. Announces Fourth ANDA Submission In 2014 6/19/2014
Type 2 Diabetes: Boehringer Ingelheim Pharmaceuticals, Inc. And Eli Lilly and Company (LLY) Announce Resubmission Of New Drug Application For Empagliflozin To FDA 6/18/2014
IGI Laboratories, Inc. Announces Sixteenth ANDA Submission 6/18/2014
Chia-Tai Tianqing Files IND For Biotech Product Licensed From Alphamab 6/18/2014
FDA Accepts New Drug Application For Symplmed's Prestalia® For The Treatment Of Hypertension 6/17/2014
Pfizer Inc. (PFE) Announces Submission Of Biologics License Application To The FDA For Investigational Meningococcal B Vaccine 6/17/2014
Novartis AG (NVS) Submits Application To The FDA For Meningitis B Vaccine Candidate Bexsero® To Help Protect US Adolescents And Young Adults 6/17/2014
Flamel Technologies (FLML) Receives Class 1 Response Designation For Second NDA 6/16/2014
Avion Pharmaceuticals, Announces Positive Feedback From The FDA On Two New Drug Applications 6/16/2014
Enanta Pharmaceuticals, Inc. Announces U.S. FDA Grants Priority Review To AbbVie (ABBV) For Investigational, All-Oral, Interferon-Free Regimen For Genotype 1 Chronic Hepatitis C 6/16/2014
Sucampo Pharmaceuticals, Inc. (SCMP) Issues Statement Regarding Anesthetic and Analgesic Drug Products Advisory Committee Meeting's Vote 6/13/2014
Shire Pharmaceuticals Group plc (SHPGY) Agrees To FDA Request To Conduct Clinical Trials Investigating The Potential Use of Vyvanse® (lisdexamfetamine dimesylate) In Preschool-Age Children With ADHD 6/12/2014
Progenics Pharmaceuticals, Inc. (PGNX) Stock Trading Halted Today; FDA Advisory Committee To Consider And Provide Recommendations Regarding Peripherally-Acting Opioid Receptor Antagonists 6/11/2014
Orexigen Therapeutics, Inc. (OREX)'s Contrave: Is This The Weight Loss Drug We've Been Waiting For? 6/10/2014
Orexigen Therapeutics, Inc. (OREX)'s Diet Pill Contrave May Get FDA Approval This Week 6/10/2014
OptiNose AS Presents Positive Results From Phase 3 COMPASS Study 6/10/2014
Rockwell Medical (RMTI) Wins Appeal For Determination As Small Business For New Drug Application Filing For Triferic™ 6/9/2014
Pharmacyclics, Inc. (PCYC) Release: Supplemental New Drug Application For IMBRUVICA® Accepted By The FDA And Priority Review Granted 6/9/2014
Upsher-Smith Laboratories Receives Final NDA Approval For Vogelxo™ (Testosterone) Gel CIII 6/5/2014
Flamel Technologies (FLML) Announces Intent To Resubmit Second NDA 6/5/2014
Hyperion Therapeutics Announces Health Canada Accepts RAVICTI® New Drug Submission With Priority Review 6/3/2014
FDA Gives ProSensa Holding N.V. (RNA)'s Lead Drug Drisapersen A New Path Towards Approval 6/3/2014
IGI Laboratories, Inc. Announces Fifteenth ANDA Submission 6/2/2014
FDA Will Review Genzyme Corporation (GENZ)'s Lemtrada Resubmission; Agency Action Expected In Q4 2014 5/30/2014
Newron Pharmaceuticals (NWRN) Release: Safinamide New Drug Application Submitted To The FDA 5/29/2014
Adamis Pharmaceuticals (ADMP) New Drug Application To FDA For Its Epinephrine Pre-Filled Syringe 5/29/2014
Rockwell Medical (RMTI) Announces FDA Acceptance For Filing Of Triferic™ New Drug Application 5/28/2014
Mallinckrodt Pharmaceuticals (MNK)’ New Drug Application Accepted For Review By FDA 5/28/2014
QRxPharma Ltd. (QRXPY) Receives Complete Response Letter From FDA Regarding Moxduo® NDA 5/27/2014
InterMune, Inc. (ITMN) Announces Resubmission Of NDA For Pirfenidone For The Treatment Of Patients With IPF 5/27/2014
AbbVie (ABBV) Files New Drug Submission To Health Canada For Its Investigational, All-Oral, Interferon-Free Therapy For The Treatment Of Hepatitis C 5/22/2014
Novo Nordisk A/S (NVO): FDA Schedules Advisory Committee Meeting For Liraglutide 3 Mg For The Treatment Of Obesity 5/21/2014
Antibe Therapeutics Inc. Announces Submission Of Clinical Trial Application To Health Canada For ATB-346 5/21/2014
Shire Plans To Submit A New Drug Application To FDA For Lifitegrast For Dry Eye Disease In Adults 5/19/2014
Pfizer Inc. (PFE) Pursues Early Approval For Breast Cancer Drug 5/19/2014
Novartis AG (NVS)'s Heart Drug Rejected By FDA 5/19/2014
Shire Plans To Submit A New Drug Application To FDA For Lifitegrast For Dry Eye Disease In Adults 5/16/2014
Teva Pharmaceutical Industries Limited (TEVA) Announces FDA Acceptance Of sNDA Filing For Pediatric Indication for QNASL® (Beclomethasone Dipropionate) Nasal Aerosol 5/13/2014
Janssen Pharmaceutical Inc. Release: Supplemental New Drug Applications For Once-Monthly Long-Acting Therapy INVEGA® SUSTENNA® (Paliperidone Palmitate) Submitted To The FDA For The Treatment Of Schizoaffective Disorder 5/13/2014
Innovus Pharma Files For The Female Sexual Interest/Arousal Disorder (FSI/AD) Expanded Label Indication For Its Zestra® Product In Canada 5/13/2014
Kythera Biopharmaceuticals (KYTH) Submits New Drug Application For ATX-101 As First-In-Class Treatment For The Reduction Of Submental Fat 5/13/2014
VIVUS, Inc. (VVUS)'s Diet Pill Faces Generic Threat From Actavis (ACT) 5/12/2014
IGI Laboratories, Inc. Receives Tentative Approval Of Generic Equivalent For Diclofenac Sodium Topical Solution 1.5% 5/7/2014
Pacira Pharmaceuticals, Inc. (PCRX) Announces sNDA Submission For EXPAREL Nerve Block Indication 5/7/2014
Janssen Research & Development Submits Supplemental New Drug Application To FDA For OLYSIO™ (Simeprevir) For Once-Daily Use In Combination With Sofosbuvir For 12 Weeks For The Treatment Of Adult Patients With Genotype 1 Chronic Hepatitis C 5/7/2014
Medivir AB (MVRBF) Release: A Supplemental New Drug Application Has Been Submitted To The FDA For Simeprevir In Combination With Sofosbuvir 5/7/2014
Merck & Co., Inc. (MRK) Announces FDA Acceptance For Review Of MK-3475 Biologics License Application For Advanced Melanoma 5/6/2014
Astellas Pharma Inc. (ALPMY) And Medivation, Inc. (MDVN) Receive Priority Review From FDA For XTANDI® (Enzalutamide) Capsules In Chemotherapy-Naive Advanced Prostate Cancer 5/6/2014
FDA Panel Rejects Merck & Co., Inc. (MRK) Respiratory Pill Singulair For Over-The-Counter Use 5/6/2014
Back To The Drawing Board For The Medicines Company (MDCO), As The FDA Denies Antiplatelet Agent Cangrelor 5/2/2014
FDA Denies Acorda Therapeutics (ACOR)'s Epilepsy Drug PLUMIAZ™ 5/2/2014
Parion Sciences Receives FDA Acceptance Of The Investigational New Drug Application For Clinical Testing Of P-321 Ophthalmic Solution For The Treatment Of Dry Eye Disease 5/1/2014
The Medicines Company (MDCO) Receives Complete Response Letter From FDA Requesting Additional Information For New Drug Application For Its Antiplatelet Agent Cangrelor 5/1/2014
FDA Accepts For Review Otsuka Pharmaceutical Co., Ltd. And H. Lundbeck A/S (LUN.CO)’s Supplemental New Drug Application To Expand Abilify Maintena® (Aripiprazole) Labelling 4/30/2014
Purdue Pharma L.P. Submits NDA For Once-Daily Hydrocodone Bitartrate Extended-Release Tablets Formulated To Incorporate Abuse-Deterrent Properties 4/30/2014
Collegium Pharmaceutical, Inc. Announces Successful Pre-NDA Meeting With FDA For Oxycodone DETERx®, Its Extended-Release, Abuse-Deterrent Product For The Treatment Of Chronic Pain 4/29/2014
Sarepta Therapeutics (SRPT) Erupts On Optimism Over Muscular Dystrophy Drug; Stock Up +39.26% At Market Close (April 21, 2014) 4/28/2014
IntelGenx Corp. And RedHill Biopharma Ltd. (RDHL) Provide An Update On FDA's Ongoing Review Of The NDA For Migraine Versafilm™ Product 4/24/2014
QRxPharma Ltd. (QRXPY) Fails To Win Panel Backing For New Painkiller Moxduo 4/23/2014
FDA Accepts Gilead Sciences, Inc. (GILD)'s Two NDAs For HIV Therapy 4/22/2014
Enanta Pharmaceuticals, Inc. Announces New Drug Application Submission To The FDA For All-Oral, Interferon-Free Hepatitis C Regimen 4/22/2014
Amgen (AMGN)'s Heart Failure Drug Ivabradine Wins Fast Track Status From The FDA 4/21/2014
Cubist Pharmaceuticals, Inc. (CBST) Announces Submission Of New Drug Application For Investigational Antibiotic Ceftolozane/Tazobactam 4/21/2014
Boehringer Ingelheim Pharmaceuticals, Inc. And Eli Lilly and Company (LLY) Announce New Drug Application Filing In The U.S. For The Combination Tablet Of Empagliflozin And Linagliptin 4/14/2014
Bristol-Myers Squibb Company (BMY) Submits New Drug Application To FDA For A Fixed-Dose Combination Tablet Of Atazanavir Sulfate With Cobicistat For People Living With HIV-1 4/14/2014
Bay Area's IMPAX Laboratories, Inc. (IPXL) Tries Again With Once-Rebuffed Parkinson's Drug Rytary 4/11/2014
Janssen Research & Development Release: Supplemental New Drug Application For IMBRUVICA™ (ibrutinib) Submitted To The U.S. FDA 4/8/2014
Pharmacyclics, Inc. (PCYC) Files Supplemental New Drug Application For IMBRUVICA With Phase III CLL Study Data 4/8/2014
Bristol-Myers Squibb Company (BMY) Submits NDAs For Daclatasvir And Asunaprevir To The FDA For Hepatitis C Drugs 4/7/2014
Gilead Sciences, Inc. (GILD)'s Ledipasvir/Sofosbuvir Fixed-Dose Combo Hep C Tablet Wins FDA Priority Review 4/7/2014
TWi Pharmaceuticals, Inc.i Announces ANDA Approval Of Generic Procardia Xl® Tablets 30 Mg, 60 Mg And 90 Mg In The United States 4/7/2014
Sanofi (France) (SAN.PA) Will Try Again, To Resubmit Lemtrada Application For FDA Review 4/7/2014
Ventrus Biosciences, Inc.  (VTUS) Receives Date For Type B Pre-NDA Meeting With FDA For DOLIZEM (Diltiazem Hydrochloride Cream) In Anal Fissures 4/4/2014
FDA Accepts The Filing Of The Medicines Company (MDCO)'s US Biologic License Application For Fibrocaps Hemostatic Agent 4/4/2014
Helix Biopharma (CC:HBP) Submits L-DOS47 Investigational New Drug Application With FDA 4/4/2014
MannKind Corporation (MNKD) Rockets As FDA Panel Backs Inhaled Diabetes Drug Afrezza; Stock Up 73.88% At Market Close (April 2, 2014) 4/4/2014
Astellas Pharma US Announces European Regulatory Submission For XTANDI® (enzalutamide) Capsules For Chemotherapy-Naive Metastatic Prostate Cancer 4/3/2014
Omeros Corporation (OMER) Release: Investigational New Drug Application Cleared By FDA For OMS721 In Thrombotic Microangiopathies 4/3/2014
Immune Response BioPharma Announces FDA BLA Fee Waiver Granted Clears Path For REMUNE Approval 4/2/2014
Janssen Research & Development Submits New Drug Application To FDA For A Fixed-Dose Combination Tablet Of HIV-1 Medicine Darunavir With Cobicistat As Part Of Combination HIV Therapy 4/2/2014
FDA Panel Backs Durata Therapeutics, Inc.  (DRTX)'s Two New Anti-Infective Drugs 4/1/2014
GlaxoSmithKline (GSK) Pulls Bid To Extend Use Of Kidney Drug To Ovarian Cancer 3/31/2014
pSivida Corp (PSDV) Announces Resubmission Of New Drug Application For ILUVIEN® 3/27/2014
OptiNose AS Announces FDA Acceptance Of New Drug Application For AVP-825 For The Acute Treatment Of Migraine 3/27/2014
Alimera Sciences (ALIM) Announces Resubmission Of ILUVIEN® New Drug Application To FDA 3/27/2014
AVANIR Pharmaceuticals (AVNR) Announces Acceptance Of New Drug Application For AVP-825 For The Acute Treatment Of Migraine 3/27/2014
Novartis AG (NVS)'s Serelaxin Should Not Be Approved For Heart Failure: FDA Staff 3/26/2014
Rockwell Medical (RMTI) Submits New Drug Application For Triferic™ For The Treatment Of Iron Replacement In Chronic Kidney Disease Patients On Hemodialysis 3/24/2014
Elite Pharmaceuticals, Inc. (ELI) Announces Supplemental Application For Site Transfer Of Isradipine 3/24/2014
Novo Nordisk A/S (NVO) Sees Chance Of U.S. Tresiba Launch Before Rival Products 3/21/2014
Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company (LLY) Diabetes Drug Empagliflozin Wins EU Panel's Backing 3/21/2014
EU Agency Backs New Drugs From Johnson & Johnson (JNJ), Eli Lilly and Company (LLY) And Takeda 3/21/2014
Arbor Pharmaceuticals Announces FDA Acceptance For Filing Of Its Second NDA 3/20/2014
NDA For Eagle Pharmaceuticals (EGRX)' Orphan Drug Ryanodex® For The Treatment Of Malignant Hyperthermia Accepted By FDA, Priority Review Granted 3/20/2014
Provepharm Announces That Its Partner In Japan, Daiichi Sankyo, Inc. (4568.t) Has Filed An NDA For The Marketing Of The Methylene Blue Injection Medicinal Product In Japan, Made Out Of Proveblue® Methylene Blue Active Substance 3/19/2014
Astellas Pharma Inc. (ALPMY) And Medivation, Inc. (MDVN) Submit Supplemental New Drug Application For XTANDI (Enzalutamide) For Chemotherapy-Naive Advanced Prostate Cancer 3/18/2014
Sucampo Pharmaceuticals, Inc. (SCMP), Takeda Pharmaceutical Co. Ltd. (TKPYY)'s New Drug Application For AMITIZA® Dealt A Huge Setback 3/17/2014
FDA Accepts Veloxis Pharmaceuticals A/S (VELO)'s New Drug Application For Envarsus® 3/14/2014
IGI Laboratories, Inc. Announces First ANDA Approval 3/12/2014
Hemispherx Biopharma (HEB) Announces Plans To File For Regulatory Approval Of Ampligen® To Treat Chronic Fatigue Syndrome (CFS) In Three Additional Latin America Countries 3/11/2014
FDA Says OK To Review Of Lundbeck Inc. (LUN.CO)'s New Drug Application For Intravenous Carbamazepine 3/10/2014
Eli Lilly and Company (LLY) Says New Drug Application Rejected On Facility Issues 3/6/2014
Navidea Biopharmaceuticals (NAVB) Announces Acceptance For Review Of An Additional sNDA To Further Expand Lymphoseek® Labeling 3/5/2014
Forest Laboratories, Inc. (FRX) And Adamas Pharmaceuticals Announce Forest’s Submission Of New Drug Application For Memantine Extended Release And Donepezil Fixed-Dose Combination For Alzheimer’s Disease 3/4/2014
IGI Laboratories, Inc. Announces Fourteenth ANDA Submission 3/4/2014
IntelGenx Corp. And RedHill Biopharma Ltd. (RDHL) Submit Response To FDA CRL For Versafilm™ Product For Migraines 3/3/2014
Forest Laboratories, Inc. (FRX) Submits A New Drug Application For Nebivolol And Valsartan Combination In Hypertension 2/27/2014
Biocryst Pharmaceuticals (BCRX) Announces Peramivir NDA Acceptance By The FDA 2/25/2014
Regeneron Pharmaceuticals, Inc. (REGN) Announces FDA Acceptance Of EYLEA® (Aflibercept) Injection Supplemental Biologics License Application For The Treatment Of Macular Edema Following Branch Retinal Vein Occlusion 2/24/2014
FDA Accepts For Review Merck & Co., Inc. (MRK)’s Biologics License Application For V503, Investigational 9-valent Human Papillomavirus Vaccine 2/20/2014
Egalet Receives Fast Track Designation For Egalet-001 And Egalet-002 For Moderate To Severe Pain 2/20/2014
FDA Accepts Filing Of The Medicines Company (MDCO)'s New Drug Application For Intravenous Antibiotic Oritavancin With Priority Review 2/19/2014
Navidea Biopharmaceuticals (NAVB) Announces Priority Review For The sNDA To Expand Lymphoseek® Labeling For Sentinel Lymph Node Detection In Patients With Head And Neck Cancer 2/18/2014
Cellceutix (CTIX) Submits Investigational New Drug Application (IND) For Clinical Trial Of New Anti-Psoriasis Drug, Enrollment Underway In Phase 2b Clinical Trials Of Brilacidin 2/18/2014
FDA Rejects Wider Use Of Bayer AG (BAYN.DE)'s Xarelto Drug For Acute Coronary Syndrome 2/14/2014
FDA Declines To Approve DURECT Corporation (DRRX)'s Pain Drug; Stock Drops -20.51% At Market Close (February 13, 2014) 2/14/2014
FDA Staff: The Medicines Company (MDCO)'s Cangrelor Drug Should Not Be Approved 2/12/2014
Gilead Sciences, Inc. (GILD) Seeks FDA OK Of Oral Attack On Hepatitis C 2/12/2014
FDA Wants More Info On Sprout Pharmaceuticals's Female Libido Pill 2/11/2014
Scancell: SCIB1 Granted FDA Orphan Drug Status 2/11/2014
Sprout Pharmaceuticals Receives Clear Guidance From FDA On Path Forward To Resubmit New Drug Application For Flibanserin, The First Potential Medical Treatment For Hypoactive Sexual Desire Disorder In Premenopausal Women 2/10/2014
Spectrum Pharmaceuticals, Inc. (SPPI) Announces FDA’s Acceptance Of NDA Filing For Beleodaq™ (Belinostat) For Injection, A Novel Pan-HDAC Inhibitor 2/6/2014
Repros Therapeutics Inc. (RPRX) Meets With FDA To Discuss Data Requirements For Androxal® In The Treatment Of Secondary Hypogonadism 2/6/2014
FDA Grants Acceptance To File And Priority Review For TopoTarget A/S's Beleodaq™ (Belinostat) NDA In PTCL 2/6/2014
FDA Grants Fast Track Designation To Omeros Corporation (OMER) OMS824 Huntington's Disease Program 2/5/2014
FDA Denies IntelGenx Corp., RedHill Biopharma Ltd. (RDHL)'s Acute Migraine Drug 2/4/2014
Salix Pharmaceuticals, Ltd. (SLXP) Announces Acceptance Of NDA Filing For Budesonide Foam In Patients With Distal Ulcerative Colitis 1/30/2014
FDA Panel Gives Blessing To Merck & Co., Inc. (MRK)'s Ragweed Allergy Pill 1/29/2014
Thousands Of Prostate Patients Denied Astellas Pharma Inc. (ALPMY) Drug That Can Extend Life In Watchdog U-Turn 1/29/2014
Medac Pharma, Inc. Secures FDA Acceptance Of A New Drug Application (NDA) For Methotrexate-Containing Autopen 1/27/2014
Heron Therapeutics, Inc. (APPA) Provides Update On Sustol Resubmission 1/27/2014
No Serious Side Effects With Merck & Co., Inc. (MRK)'s Experimental Allergy Pill — FDA Documents 1/27/2014
ALK-Abello A/S Announces Posting Of Briefing Documents For FDA Advisory Committee Meeting On The Ragweed Sublingual Tablet 1/24/2014
VIVUS, Inc. (VVUS) And Auxilium Pharmaceuticals (AUXL) Announce FDA Acceptance Of Supplemental Filing Seeking An Update Of Prescribing Information For STENDRA (Avanafil) 1/23/2014
Actavis (ACT) Comments On Notification To Allergan Inc. (AGN) Of Submission Of Application For Restasis® 1/23/2014
AMAG Pharmaceuticals, Inc. (AMAG) Drops As The FDA Turns Down Application For Iron Deficiency Drug Feraheme® 1/22/2014
VIVUS, Inc. (VVUS) And Auxilium Pharmaceuticals (AUXL) Announce FDA Acceptance Of Supplemental Filing Seeking An Update Of Prescribing Information For STENDRA (Avanafil) 1/21/2014
FDA Panel Once Again Rejects Wider Use Of Johnson & Johnson (JNJ) Drug 1/17/2014
Merck & Co., Inc. (MRK)'s Blood Thinner, Vorapaxar, Gets "Yes" Vote From FDA Panel 1/16/2014
Amarin Corporation PLC (AMRN) Slumps A Bit As FDA Delays Decision On Vascepa Trial Design 1/16/2014
FDA Staff Unconvinced By Johnson & Johnson (JNJ)'s Latest Xarelto Application 1/15/2014
Bristol-Myers Squibb Company (BMY) Ties Hepatitis C Success To Rival Gilead Sciences, Inc. (GILD)'s Pill 1/15/2014
Chelsea Therapeutics, Inc. (CHTP) Rockets Before Market Opens After Northera Finally Wins FDA Panel Backing 1/15/2014
Daiichi Sankyo, Inc. (4568.t) Submits SAVAYSA™ (Edoxaban) Tablets New Drug Application To The FDA For Once-Daily Use For Stroke Risk Reduction In Atrial Fibrillation And For The Treatment And Prevention Of Recurrence Of Venous Thromboembolism 1/14/2014
INSYS Therapeutics Announces Details Of Product Development Pipeline 1/13/2014
Merck & Co., Inc. (MRK) Initiates Rolling Submission Of U.S. Biologics License Application For MK-3475, An Investigational Anti-PD-1 Immunotherapy, In Patients With Advanced Melanoma 1/13/2014
Ampio Pharmaceuticals, Inc. (AMPE) Injects First Patients In 2nd Phase III, Pivotal Clinical Trial For Ampion™(The STEP Study) For Its FDA Biological License Application (BLA) 1/13/2014
Cynapsus Therapeutics Announces Completion Of Human Healthy Volunteer Crossover Study Results For APL-130277 1/13/2014
FDA Accepts New Drug Application For Gilead Sciences, Inc. (GILD)'s Idelalisib for the Treatment of Refractory Indolent Non-Hodgkin's Lymphoma 1/13/2014
Chelsea Therapeutics, Inc. (CHTP) Blues: FDA Reviewer Still Finds Problems With Fainting Drug Northera 1/13/2014
NPS Pharmaceuticals, Inc. (NPSP) Announces FDA Acceptance Of Biologics License Application For Natpara® For The Treatment Of Hypoparathyroidism 1/8/2014
Karyopharm Therapeutics (KPTI) Announces Submission Of New Animal Drug Application Effectiveness And Safety Sections For Novel, Oral, Small-Molecule Selective Inhibitor Of Nuclear Export (SINE) Verdinexor For Canine Lymphoma To FDA's Center For Veterinary Medicine 1/7/2014
AEterna Zentaris (AEZS) NDA For Macimorelin Acetate In AGHD Accepted For Filing By The FDA 1/6/2014
IGI Laboratories, Inc. Completes Its Sixth ANDA Filing For 2013 Under Joint Drug Development And Commercialization Agreement 1/2/2014
FDA Turns Its Nose Up At Genzyme Corporation (GENZ)'s Lemtrada™ 12/31/2013
Veloxis Pharmaceuticals A/S (VELO) Announces NDA Submission For Envarsus® In Kidney Transplant Recipients 12/30/2013
Cubist Pharmaceuticals, Inc. (CBST) Announces FDA Acceptance Of Tedizolid New Drug Application With Priority Review 12/30/2013
Actavis (ACT) Denies FDA' Contraceptive Patch, Seeks More Data 12/30/2013
Swedish Orphan Biovitrum To Temporarily Withdraw New Drug Application For Orfadin® Oral Suspension In The US 12/27/2013
ALK Announces FDA Advisory Committee To Review Ragweed Sublingual AIT Tablet 12/27/2013
FDA Agrees To Review Eli Lilly and Company (LLY)/Boehringer Ingelheim Corporation's Lantus Biosimilar 12/23/2013
Titan Pharmaceuticals (TTP) Receives Official Minutes From FDA Meeting On Probuphine New Drug Application 12/23/2013