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Clinical - BLA/NDA/ANDA
Lannett (LCI) Receives FDA Approval For Temozolomide Capsules 2/11/2016
Shire (SHPG) Partner, Shionogi, Submits New Drug Application In Japan For ADHD Treatment For Children 2/11/2016
Patient Deaths Push the FDA to Slap Full Clinical Hold on CTI BioPharma's Cancer Drug Pacritinib 2/10/2016
Johnson & Johnson (JNJ) Falls as FDA Staffers Back Celltrion (068270.KQ)'s Remicade Biosimilar 2/9/2016
FDA Delays Decision on Sarepta (SRPT)'s Muscle-Wasting Disorder Drug 2/9/2016
Crohn's and Colitis Foundation of America Release: Crohn's and Colitis Foundation of America Holds Meeting On Application For First Biosimilar For Use With Crohn's & Colitis Patients 2/9/2016
FDA Acknowledges Receipt Of Resubmission Of Shire (SHPG)'s New Drug Application For Lifitegrast For Dry Eye Disease In Adults 2/5/2016
FDA Spurns Vertex (VRTX) Application for Expanded Use of Kalydeco 2/5/2016
IMPAX Labs (IPXL) Receives Tentative FDA Approval For Generic Version Of Vytorin (ezetimibe And simvastatin) Tablets, 10 Mg/10 Mg, 10 Mg/20 Mg, 10 Mg/40 Mg And 10 Mg/80 Mg 2/2/2016
Acadia (ACAD) Announces FDA Advisory Committee Meeting To Review NUPLAZID (Pimavanserin) For The Treatment Of Parkinson’s Disease Psychosis 2/1/2016
Synergy Pharma Files New Drug Application For Plecanatide In Chronic Idiopathic Constipation 2/1/2016
Dr. Reddy's Laboratories Ltd. (RDY) Receives FDA Tentative Approval For Zenavod (Doxycycline) Capsules, 40 Mg For The Treatment Of Rosacea In Adults 2/1/2016
Exelixis (EXEL) Announces FDA Deems New Drug Application Sufficiently Complete And Grants Priority Review For Cabozantinib As A Treatment For Advanced Renal Cell Carcinoma 1/28/2016
Merck & Co. (MRK) Announces FDA Acceptance Of Biologics License Application For Bezlotoxumab, An Investigational Antitoxin For Prevention Of Clostridium Difficile Infection Recurrence 1/27/2016
FDA Accepts Amgen (AMGN)'s Biosimilar Biologics License Application For ABP 501 1/26/2016
Aratana Therapeutics (PETX) Files For First FDA Approval 1/26/2016
US FDA Accepts Green Cross' Biologics License Application For IVIG-SN 1/26/2016
Shire (SHPG) Resubmits New Drug Application For Lifitegrast To U.S. FDA 1/25/2016
Valeant (VRX) Announces FDA Acceptance Of BLA Submission For Brodalumab In Moderate-To-Severe Plaque Psoriasis 1/25/2016
Eli Lilly (LLY) Release: U.S. FDA Accepts Filing Of Cardiovascular Outcomes Data For Jardiance (empagliflozin) 1/25/2016
Allergan (AGN) Announces FDA Approval Of Updated Label For New Dosing Regimen For DALVANCE (dalbavancin) 1/21/2016
Agenus (AGEN) Announces Clearance Of Investigational New Drug Applications By The FDA For Anti-CTLA-4 And Anti-GITR Antibodies 1/21/2016
With Snowmageddon Predicted for East Coast, FDA Postpones Meeting Over Sarepta (SRPT)’s DMD Drug 1/21/2016
Eli Lilly (LLY) And Incyte (INCY) Announce Submission Of New Drug Application To FDA For Oral Once-Daily Baricitinib For Treatment Of Moderate-To-Severe Rheumatoid Arthritis 1/19/2016
FDA Turns Down Both BioMarin (BMRN) and Sarepta (SRPT)’s DMD Drug Applications, Stocks Plunge 1/19/2016
Up or Down, Three Biotechs that Will Face Major Decisions Soon 1/19/2016
Eisai Inc. (ESALF.PK)'s Lenvatinib Receives FDA Priority Review For The Potential Treatment Of Advanced Renal Cell Carcinoma In Combination With Everolimus 1/18/2016
Adamis (ADMP) Announces FDA Acceptance Of Resubmission Of Its Epinephrine Pre-Filled Syringe NDA 1/15/2016
FDA Delays Decision of Bay Area-Based Heron (HRTX)'s Nausea Drug Sustol 1/15/2016
FDA Rejects BioMarin (BMRN)'s Much-Anticipated DMD Drug 1/15/2016
CureDuchenne Responds To FDA Decision On Drisapersen For Duchenne Muscular Dystrophy 1/14/2016
Genentech (RHHBY) Release: FDA Grants Priority Review For Venetoclax New Drug Application 1/12/2016
Mylan (MYL) Confirms FDA Submission Of ANDA For Generic Advair Diskus 1/12/2016
Gilead (GILD) Submits New Drug Application To U.S. Food And Drug Administration For Tenofovir Alafenamide (TAF) For The Treatment Of Chronic Hepatitis B 1/12/2016
Amerigen Pharmaceuticals And DIPHARMA Announce First Regulatory Submission For Miglustat 100mg Capsules 1/12/2016
CASI Pharmaceuticals  (CASI)' Import Drug Registration Application For MARQIBO Accepted For Review By CFDA 1/12/2016
U.S. and European Regulators Accept Applications For AbbVie (ABBV)'s Venetoclax, The First Potential BCL-2 Inhibitor For Chronic Lymphocytic Leukemia 1/12/2016
PTC Therapeutics (PTCT) Outlines Business Priorities For The Development And Commercialization Of Translarna And Progress Of The Company Pipeline 1/11/2016
PTC Therapeutics (PTCT) Completes Rolling NDA Submission To FDA And Submits Phase 3 ACT DMD Clinical Trial Results To European Medicines Agency for Translarna (ataluren) For Treatment Of Nonsense Mutation Duchenne Muscular Dystrophy 1/8/2016
Regeneron (REGN) And Sanofi (SNY) Announce Sarilumab Biologics License Application Accepted For Review By US FDA 1/8/2016
Ariad (ARIA) And Otsuka Pharma Submit New Drug Application In Japan For Ponatinib 1/8/2016
U.S. FDA Grants Priority Review To AbbVie (ABBV) For Supplemental New Drug Application For VIEKIRA PAK (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets) Without Ribavirin In Genotype 1b Chronic Hepatitis C Virus Patients With Compensated Cirrhosis 1/7/2016
Enanta Pharmaceuticals, Inc. Announces The U.S. FDA Grants Priority Review To AbbVie (ABBV)’s Supplemental New Drug Application For VIEKIRA PAK Without Ribavirin In Genotype 1B Chronic Hepatitis C Virus Patients With Compensated Cirrhosis 1/7/2016
Oncurious NV Announces FDA Acceptance Of Investigational New Drug (IND) Application For A Phase I/IIa Study With TB-403 For The Treatment Of Pediatric Brain Tumors 1/7/2016
Anacor (ANAC) Submits New Drug Application To The FDA For Crisaborole Topical Ointment, 2% For The Treatment Of Mild-To-Moderate Atopic Dermatitis 1/7/2016
Baxalta (BXLT) Announces Priority Review Status Granted By Health Canada For Irinotecan Liposome Injection (Nal-IRI) For New Drug Submission 1/7/2016
BioInvent (BOVNF) Announces FDA Acceptance Of The Investigational New Drug Application For The Phase I/IIa Study With TB-403 1/7/2016
Medicure Inc. (MCU) Announces ANDA Collaboration With Apicore 1/6/2016
Investors Await Four Key FDA Decisions in the First Quarter of 2016 1/5/2016
Gilead (GILD) Gets FDA Priority Review for Hepatitis C Combo Drug 1/5/2016
CTI BioPharma And Baxalta (BXLT) Complete Submission Of New Drug Application For Pacritinib For Unmet Medical Need In Myelofibrosis 1/5/2016
ANI Pharma Closes Transaction To Acquire Two NDAs From Merck & Co. (MRK) For $75 Million 1/5/2016
Vericel (ASTM) Submits Biologics License Application To The FDA For MACI For The Treatment Of Cartilage Defects In The Knee 1/5/2016
Mylan (MYL) Launches Generic Ortho Tri-Cyclen Lo Tablets 1/5/2016
Gilead (GILD) Announces U.S. FDA Priority Review Designation For Sofosbuvir/Velpatasvir For Treatment Of All Genotypes Of Chronic Hepatitis C Infection 1/5/2016
Teligent, Inc. Announces Fourteenth & Fifteenth ANDA Submissions Of 2015 12/31/2015
Epizyme (EPZM) Announces FDA Acceptance Of Investigational New Drug Application For Tazemetostat In Diffuse Large B-cell Lymphoma 12/28/2015
Sanofi (SNY) Pays $20 Million Milestone and Redeems Priority Review Voucher for Zealand Pharma  (ZEAL.CO)’s LixiLan 12/23/2015
Cardiome Pharma Corp. (COM.TO) Files New Drug Submission Seeking Canadian Approval Of Intravenous vernakalant 12/23/2015
Sanofi (SNY) Submits New Drug Application For The Once-Daily Fixed-Ratio Combination Of Insulin Glargine And Lixisenatide 12/23/2015
Exelixis (EXEL) Completes Submission Of New Drug Application For Cabozantinib For The Treatment Of Advanced Renal Cell Carcinoma 12/23/2015
CSL Behring Submits New Drug Application To Japan's Pharmaceuticals And Medical Devices Agency For rIX-FP For Hemophilia B Patients 12/21/2015
Vernalis PLC (VNLPY.PK) Announces Successful Completion Of CCP-07 Pivotal Single-Dose Comparative Bioavailability Study 12/21/2015
Merck & Co. (MRK) Provides Update On European Medicines Agency Marketing Authorisation Application For Investigational Chronic Hepatitis C Therapy Elbasvir/Grazoprevir 12/18/2015
Teligent, Inc. Announces Submission Of Two Topical ANDAs 12/17/2015
Kindred Bio (KIN) Submits KIND-012 New Animal Drug Application Technical Section For Chemistry, Manufacturing, And Controls To FDA 12/17/2015
Catalyst Pharmaceuticals (CPRX) Completes NDA Submission To FDA For Firdapse For The Treatment Of Lambert-Eaton Myasthenic Syndrome And Congenital Myasthenic Syndromes 12/17/2015
FDA Review of Clovis Oncology (CLVS)'s Lung Cancer Therapy Extended by Three Months 12/16/2015
Zavante Announces FDA Endorsed ZTI-01 Development Plan To Include A Single Pivotal Trial 12/16/2015
FDA Accepts Biologics License Application For PaxVax’s Single-Dose Oral Cholera Vaccine Vaxchora 12/16/2015
FDA Panel Refuses to Back Merck & Co. (MRK)'s Vytorin for Heart Ailments 12/15/2015
Egalet Submits New Drug Application To FDA For ARYMO ER (Morphine Sulfate) Extended-Release Tablets 12/15/2015
KemPharm Submits NDA For KP201/APAP And Requests Priority Review From The FDA 12/15/2015
Regen BioPharma Receives FDA Clearance To Initiate Clinical Trial Of Hemaxellerate 12/15/2015
Titan Pharmaceuticals (TTP) And Braeburn Pharma Announce Date Of FDA Advisory Committee Review Of Probuphine For Opioid Addiction 12/11/2015
FDA Advisory Committee Recommends Approval Of Teva (TEVA)’s Asthma Biologic Reslizumab 12/10/2015
Pfizer (PFE) Announces FDA Acceptance Of IBRANCE (Palbociclib) Supplemental New Drug Application With Priority Review In HR+, HER2- Metastatic Breast Cancer 12/10/2015
Novo Nordisk A/S (NVO) Files For Regulatory Approval Of "Faster-Acting Insulin Aspart" In The U.S. 12/9/2015
Braeburn Pharma And Titan Pharmaceuticals (TTP) Announce Date Of FDA Advisory Committee Review Of Probuphine For Opioid Addiction 12/9/2015
Ocular Therapeutix (OCUL) Announces FDA Acceptance Of NDA Filing For DEXTENZA For The Treatment Of Post-Surgical Ocular Pain 12/9/2015
Pfizer (PFE) Announces U.S. FDA Acceptance And Priority Review Of Supplemental New Drug Application For XALKORI® (Crizotinib) For The Treatment Of Patients With ROS1-Positive Metastatic Non-Small Cell Lung Cancer 12/8/2015
Adamis (ADMP) Announces NDA Resubmission Of Its Epinephrine Pre-Filled Syringe Application To The FDA 12/7/2015
AbbVie (ABBV) Announces FDA Acceptance Of New Drug Application For A Once-Daily Formulation Of VIEKIRA PAK (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) To Treat Genotype 1 Chronic Hepatitis C Virus Infection 12/2/2015
Avinger Announces Filing Of 510(K) Application For Enhanced Version Of Pantheris 12/2/2015
Enanta Pharmaceuticals, Inc. Announces FDA Acceptance Of AbbVie (ABBV)’s New Drug Application For A Once-Daily Formulation Of VIEKIRA PAK For The Treatment Of Genotype 1 Chronic Hepatitis C Virus Infection 12/2/2015
Blue Earth Diagnostics And Siemens (SI)’ PETNET Solutions Announce FDA Acceptance Of NDA Filing For Fluciclovine 12/2/2015
FDA Denies Approval of Repros Therapeutics (RPRX)' Enclomiphene 12/1/2015
Teligent, Inc. Announces Eleventh ANDA Submission Of 2015 12/1/2015
Former Sarepta (SRPT) CEO's Feelings About BioMarin (BMRN)'s Drug Panel 11/30/2015
BioMarin (BMRN) Stock Halted as FDA Bashes Muscle Wasting Drug 11/30/2015
Amgen (AMGN)'s First Biosimilar Biologics License Application For ABP 501 Submitted To FDA 11/30/2015
FDA Passes On Expanded Approval of Bristol-Myers Squibb (BMY)'s Opdivo 11/30/2015
Eisai Inc. (ESALF.PK) And Arena (ARNA) Announce FDA Acceptance Of New Drug Application For Extended Release Formulation Of Lorcaserin 11/30/2015
Janssen Biotech Inc. (JNJ) Submits Applications Seeking Approval Of STELARA In United States And European Union For Crohn's Disease 11/30/2015
Investors Hold Their Breath as BioMarin (BMRN)'s DMD Drug Gets Grilled by the FDA Today 11/25/2015
Debiopharm's Partner Yakult Honsha Announces Elplat Approbation In Gastric Cancer In Japan 11/24/2015
CTI BioPharma Initiates Rolling Submission Of U.S. New Drug Application For Pacritinib For The Treatment Of Patients With Myelofibrosis 11/23/2015
AMAG (AMAG) Responds To Recent Complete Response Letter From The FDA For The Single-Dose, Preservative-Free Vial Of Makena 11/23/2015
Bayer HealthCare Pharmaceuticals (BAYA.F) Submits New Drug Application For LCS-16 For Pregnancy Prevention For Up To Five Years 11/20/2015
Janssen Research & Development Submits INVOKAMET XR (Canagliflozin / Metformin Hydrochloride Extended Release) for Approval by the U.S. FDA as an Adjunctive Treatment in Adults with Type 2 Diabetes 11/20/2015
Spectrum Pharma (SPPI) Submits Phase 2 Breast Cancer Protocol To FDA As Part Of An Investigational New Drug (IND) Application For Poziotinib 11/20/2015
ACCU-BREAK Pharmaceuticals, Inc. Files NDA For Unique Warfarin Potassium Tablets 11/19/2015
FDA Panel Rejects Telesta (TSX:TST)'s Bladder Cancer Drug MCNA 11/19/2015
FDA Rejects AMAG (AMAG)'s Single-Dose Makena Again 11/19/2015
Novartis AG (NVS) Takes Another Shot at Amgen (AMGN) with Third Biosimilar Filing 11/19/2015
Radius Health (RDUS) Delays Osteoporosis Drug Application in the U.S. to Avoid Rush, Respect Staffers' Holidays 11/18/2015
Clovis Oncology (CLVS)'s Lung Cancer Woes is AstraZeneca PLC (AZN)'s Gain 11/18/2015
Clovis Oncology (CLVS) Plummets on Lung Cancer Drug Review Delay 11/16/2015
Janssen Biotech Inc. (JNJ) Release: Additional Efficacy And Safety Data For IMBRUVICA (Ibrutinib) Submitted To FDA 11/13/2015
China Rejects 11 Drug Apps Over Inadequate Trial Data 11/12/2015
Neos Therapeutics (NEOS) Receives Complete Response Letter From The FDA For Cotempla XR-ODT 11/11/2015
Allergan (AGN) Announces Submission of Prior Approval Supplement for RESTASIS (Cyclosporine Ophthalmic Emulsion) 0.05% Multi-Dose Preservative-Free Bottle 11/11/2015
FDA Accepts Amgen (AMGN)'s New Drug Application For Novel Intravenous Calcimimetic Etelcalcetide 11/9/2015
Collegium (COLL) Announces FDA Tentative Approval For Xtampza(TM) ER, A Novel Abuse-Deterrent Analgesic For Chronic Pain 11/9/2015
Roche (RHHBY) Announces Strategic Plan with Seven Trial Readouts Expected in Next Two Years 11/5/2015
Espero Pharmaceuticals Announces FDA Acceptance Of New Drug Application For Gonitro (Nitroglycerin Powder For Sublingual Use) 11/4/2015
GlaxoSmithKline (GSK) Presents Pipeline of 40 Drugs, 20 Up for Filing and Launch in Next 5 Years 11/4/2015
Tryton Medical Files Pre-Market Approval Application With U.S. FDA For Tryton Side Branch Stent 11/2/2015
Onco-Immunology Companies like Juno (JUNO), Novartis AG (NVS), Kite Pharma (KITE) Struggle to Mass Produce Custom Cancer Therapies 11/2/2015
Acadia (ACAD) Announces FDA Priority Review Of NUPLAZID (Pimavanserin) New Drug Application For Parkinson’s Disease Psychosis 11/2/2015
Repros Therapeutics (RPRX) Stock Plunges as FDA Advisory Panel Cancels Enclomiphene Review 10/30/2015
FDA Accepts For Filing Lipocine Inc. (LPCN)’s New Drug Application For Its Oral Testosterone Replacement Product Candidate, LPCN 1021 10/30/2015
Gilead (GILD) Submits New Drug Application To U.S. FDA For Fixed-Dose Combination Of Sofosbuvir/Velpatasvir For Treatment Of All Six Genotypes Of Hepatitis C 10/29/2015
Novartis AG (NVS) Hopes to File 10 Big Biosimilars in the Next Three Years 10/28/2015
Nephros Inc. (NEP) Announces FDA 510(k) Submission Of S100 Ultrafilter 10/27/2015
FDA Panel Votes in Favor of AstraZeneca PLC (AZN)'s Gout Drug Lesinurad 10/26/2015
Investors Hold Their Breath as Amgen (AMGN) Inches Toward U.S. Approval for Its New Cancer Immunotherapy T-Vec 10/26/2015
Tryton Medical Nears FDA Submission for Stent 10/23/2015
Supernus Pharmaceuticals (SUPN) Announces FDA Acceptance Of Snda To Add Migraine To Trokendi XR Label 10/23/2015
FDA Declines to Approve Spectrum Pharma (SPPI)'s Evomela for Injection 10/23/2015
Exelixis (EXEL) Initiates Rolling Submission Of U.S. New Drug Application For Cabozantinib For The Treatment Of Advanced Kidney Cancer 10/22/2015
Amarantus Submits Orphan Drug Designation Application To US FDA For Eltoprazine In The Treatment Of Levodopa-Induced Dyskinesia 10/22/2015
FDA Deals a Huge Blow to Shire (SHPG)'s Pipeline By Rejecting NDA for Dry Eye Drug 10/21/2015
FDA Indicates Deficiencies in Neos Therapeutics (NEOS)’s ADHD New Drug Application 10/20/2015
Tarsa Therapeutics' NDA For TBRIA, The First Oral Calcitonin For The Treatment Of Postmenopausal Osteoporosis, Accepted For Filing 10/19/2015
Avedro, Inc. Resubmits New Drug Application To FDA For Corneal Cross-Linking 10/19/2015
Hemispherx Biopharma Europe N.V./S.A. Receives Positive Opinion On Application For Orphan Designation By The European Medicines Agency For Alferon N Injection To Treat Patients With Middle East Respiratory Syndrome (MERS) 10/19/2015
FDA Seeks More Data for AstraZeneca PLC (AZN)'s Diabetes Combo Treatment 10/16/2015
BioMarin (BMRN) Announces FDA Advisory Committee To Review Drisapersen For Treatment Of Patients With Duchenne Muscular Dystrophy Amenable To Exon 51 Skipping 10/15/2015
FDA Rejects Expanded Approval of Pfizer (PFE)'s Arthritis Drug Xeljanz 10/15/2015
Lannett (LCI) Receives FDA Approval For Memantine Hydrochloride Oral Solution, 2 mg/mL 10/14/2015
Collegium (COLL) Falls in Aftermarket Trading After FDA Delays Ruling on Opiod Painkiller 10/13/2015
Allergan (AGN) Release: FDA Accepts Supplemental New Drug Application (sNDA) for DALVANCE (dalbavancin) 10/9/2015
FDA Confirms Luye Pharma’s 505(b)(2) NDA Submission 10/9/2015
Vertex (VRTX) Release: Supplemental New Drug Application For Use Of KALYDECO (Ivacaftor) In People With Cystic Fibrosis Ages 2 And Older Who Have One Of 23 Residual Function Mutations Accepted For Priority Review By FDA 10/8/2015
Bristol-Myers Squibb (BMY) Snags FDA's Priority Review for Daklinza SNDAs 10/6/2015
Turing Pharma Announces IND Filing For TUR-004 10/5/2015
IGI Laboratories, Inc. Announces Ninth ANDA Submission Of 2015 10/2/2015
Anthera Announces Initiation Of The SOLUTION Clinical Study Of Oral Sollpura (Liprotamase) Unit-Matched Therapy Of Non-Porcine Origin In People With Cystic Fibrosis 10/2/2015
Amicus (FOLD) Not Likely To Submit NDA For Migalastat Monotherapy This Year 10/2/2015
Novartis AG (NVS)'s Second Copycat Drug Takes Aim at Amgen (AMGN) Again 10/2/2015
Orexigen (OREX) Announces Submission Of Contrave New Drug Application In South Korea 10/1/2015
Jazz Pharmaceuticals (JAZZ) Announces U.S. FDA Acceptance For Filing With Priority Review Of NDA For Defibrotide For Hepatic Veno-Occlusive Disease 9/30/2015
ADMA Biologics, Inc. Receives Milestone Payment From Biotest AG For RI-002 BLA Submission To FDA 9/30/2015
Neothetics Initiates Study To Evaluate The Safety Of LIPO-202 For Body Contouring In Obese Subjects 9/30/2015
Tyme Technologies Submits Investigational New Drug Application For Oncology Drug Candidate SM-88 9/30/2015
Clovis Oncology (CLVS) Announces U.S. And E.U. Regulatory Milestones For Rociletinib In The Treatment Of Advanced EGFR-Mutant T790M+ Non-Small Cell Lung Cancer 9/30/2015
Newron Pharmaceuticals (NWRN) Release: Xadago (Safinamide) New Drug Application Late-Cycle Review Meeting Completed With FDA 9/30/2015
Sanofi (SNY) New Drug Application For Lixisenatide Accepted For Review By FDA 9/29/2015
Intersect ENT Announces FDA Submission To Seek Expanded Indication Of PROPEL Mini Steroid Releasing Implant To Treat Patients With Frontal Sinus Disease 9/29/2015
Osmotica Pharmaceutical Announces FDA Acceptance Of Filing For Ontinua ER For Alleviation Of Spasticity Resulting From Multiple Sclerosis And Strong Advancement In The Clinical Program For Osmolex ER 9/29/2015
Sun Pharma Group Stocks Dip on U.S. FDA Denial for its Epilepsy Drug 9/28/2015
Three Cancer Drugs are Up for FDA Approval in October 9/28/2015
Bristol-Myers Squibb (BMY) Announces FDA Regulatory Filing Update For The Opdivo+Yervoy Regimen In Patients With Previously Untreated Advanced Melanoma 9/28/2015
pSivida (PSDV) Announces NDA For Medidur Now Planned Using Six-Month Efficacy Data From Both Phase III Trials; FDA Concurs 9/28/2015
Titan Pharmaceuticals (TTP) Announces FDA's Acceptance Of Resubmission Of New Drug Application For Probuphine 9/28/2015
FDA Grants Eisai Inc. (ESALF.PK)'s sNDA For Eribulin Priority Review Designation For The Potential Treatment Of Advanced Soft Tissue Sarcoma 9/28/2015
Braeburn Announces FDA's Acknowledgment Of Receipt Of Probuphine NDA Resubmission; Agency Action Expected By February 27, 2016 9/28/2015
Telesta (TSX:TST) Announces FDA Advisory Committee Date For MCNA1 9/28/2015
Ocular Therapeutix (OCUL) Submits New Drug Application To FDA For DEXTENZA For The Treatment Of Post-Surgical Ocular Pain 9/28/2015
Lightlake Therapeutics Inc. (LLTP) Announces FDA Accepts For Review Adapt Pharma's NARCAN (Naloxone Hydrochloride) Nasal Spray NDA And Grants Priority Review Status 9/25/2015
Avant Diagnostics Commences Ovadx Ovarian Cancer Test Calibration In Preparation For FDA Submission 9/24/2015
FDA Accepts For Review Adapt Pharma’s NARCAN (Naloxone Hydrochloride) Nasal Spray NDA 9/24/2015
CTI BioPharma To Submit NDA For Pacritinib In Q4 Based Primarily On Data From Single Pivotal Persist-1 Trial 9/23/2015
Bausch & Lomb And NicOx SA (COX.PA) Announce FDA Acceptance Of New Drug Application For Novel Glaucoma Candidate VESNEO (Latanoprostene Bunod) 9/22/2015
IGI Laboratories, Inc. Announces Eighth ANDA Submission Of 2015 9/22/2015
FDA Accepts ADMA Biologics, Inc. License Application For RI-002 9/21/2015
FDA Grants Priority Review For Amgen (AMGN)'s Supplemental New Drug Application For Expanded Labeling Of Kyprolis (Carfilzomib) In Relapsed Multiple Myeloma 9/21/2015
Atossa Genetics, Inc. (ATOS) Announces FDA Acceptance Of Its Investigational New Drug Application To Begin A Phase II Clinical Trial Of Fulvestrant For The Treatment Of DCIS 9/21/2015
Health Canada Initiates Review Of PTC Therapeutics (PTCT)' New Drug Submission For Translarna For The Treatment Of Duchenne Muscular Dystrophy 9/18/2015
Heron (HRTX) Announces FDA Acceptance Of New Drug Application For SUSTOL 9/18/2015
FDA Accepts Scilex Pharmaceuticals' NDA Filing For ZTlido 9/16/2015
Telesta (TSX:TST) Sets Up U.S. Ops in Anticipation of Approval of Bladder Cancer Drug MCNA 9/15/2015
Vanda Pharmaceuticals, Inc. (VNDA) Announces FDA Has Accepted For Review The Fanapt Supplemental New Drug Application For Maintenance Treatment Of Schizophrenia In Adults 9/15/2015
Amicus (FOLD) Plans To Submit New Drug Application (NDA) For Migalastat For Fabry Disease Following Positive Pre-NDA Meeting With FDA 9/15/2015
FDA Panel Votes 23 to 1 Against Purdue Pharma L.P.’s New OxyContin Formulation 9/14/2015
FDA Panel Gives Green Light to Collegium (COLL)'s Painkiller Xtampza ER 9/14/2015
AbbVie (ABBV) Announces Submission Of A Supplemental New Drug Application For IMBRUVICA (ibrutinib) For Treatment-Naive Chronic Lymphocytic Leukemia 9/14/2015
Eisai Inc. (ESALF.PK) Announces FDA Acceptance Of NDA For The Review Of FYCOMPA (perampanel) Oral Suspension For Adjunctive Therapy In The Treatment Of Partial-Onset Seizures And Primary Generalized Tonic-Clonic Seizures In Patients With Epilepsy Age 12 And Older 9/14/2015
Janssen Biotech Inc. (JNJ) Release: IMBRUVICA (ibrutinib) Supplemental New Drug Application For Treatment-Naive Chronic Lymphocytic Leukemia Submitted To The U.S. FDA 9/14/2015
Breckenridge Pharmaceutical, Inc. Announces Tentative Approval For Dutasteride Soft Gelatin Capsules 9/14/2015
U.S. FDA Accepts First Digital Medicine New Drug Application For Otsuka Pharma And Proteus Digital Health, Inc. 9/11/2015
Amgen (AMGN) Submits Application To FDA For New Delivery Option For Monthly Administration Of Repatha (Evolocumab) 9/11/2015
Merrimack (MACK) Ramps Up Sales Force in Anticipation of Regulatory Approval of Pancreatic Cancer Drug 9/10/2015
SoCal's Apricus Biosciences (APRI) Clinches $27.5 Million Vitaros Pact with Allergan (AGN) 9/10/2015
Wellstat Therapeutics Corporation’ New Drug Application For Uridine Triacetate As Antidote To Overexposure To Chemotherapy Drug 5-Fluorouracil (5-FU) Accepted For Review By FDA 9/10/2015
Teva (TEVA) Announces FDA Acceptance Of A Supplemental New Drug Application For Proair Respiclick (Albuterol Sulfate) Inhalation Powder For Pediatric Patients 9/10/2015
Theravance Biopharma (TBPH) Announces FDA Acceptance Of sNDA To Expand VIBATIV (Telavancin) Labeling 9/10/2015
Chugai's ALK Inhibitor "Alectinib," New Drug Application Submitted For ALK Positive Advanced Non-Small Cell Lung Cancer In The United States 9/9/2015
Flamel Technologies (FLML) Announces FDA Acceptance Of Third NDA Filing 9/9/2015



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