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Clinical - BLA/NDA/ANDA
Opko Health (OPK) Release: FDA Accepts Resubmission Of New Drug Application For RAYALDEE 4/28/2016
FDA Spurns Otsuka Pharma, Proteus Digital Health's Drug/Device Combo 4/27/2016
Rounding Up the Experts’ Thoughts on What's Next for Sarepta (SRPT)'s DMD Drug 4/27/2016
FDA Pushes Back PDUFA Date for Dynavax (DVAX)'s Hep B Vaccine HEPLISAV-B 4/27/2016
Cerebain Biotech Today Announced It Plans to Seek FDA Approval 4/27/2016
CFDA Accepts HCV Treatments From Seven Companies For Accelerated Approval 4/27/2016
FDA Panel’s 7-6 Vote Against Sarepta (SRPT)’s DMD Drug Underlines Battle Between Science and Patient Advocates 4/26/2016
Catalyst Pharmaceuticals (CPRX) Must Run Another Study of Its Firdapse Drug: FDA 4/26/2016
Sarepta (SRPT)’s Stock a Rollercoast Ride Prior to Today’s FDA Hearing 4/25/2016
FDA Accepts Lundbeck Inc. (LUN.CO) Resubmission Of New Drug Application For Carnexiv (Carbamazepine) 4/25/2016
Sarepta (SRPT) Craters as the FDA Releases Documents Ahead of Monday’s DMD Drug Hearing 4/22/2016
FDA Craters as the TransEnterix (TRXC) Spurns SurgiBot 510(k) Submission 4/21/2016
FDA Panel Backs Cartiva's Synthetic Cartilage Implant (SCI) 4/21/2016
Aralez Announces Several Corporate Updates 4/20/2016
NicOx SA (COX.PA) Submits New Drug Application For AC-170 To U.S. FDA 4/20/2016
Roche (RHHBY)'s Pharma Head Believes Its First Cancer Immunotherapy Will Win FDA Approval Soon 4/19/2016
Bay Area's Heron (HRTX) Surges as the FDA Finds No Deficiency with SUSTOL NDA, Starts Labeling Discussions 4/19/2016
Synergy Pharma Announces Acceptance Of New Drug Application For Plecanatide, A Novel Uroguanylin Analog, In Chronic Idiopathic Constipation 4/19/2016
Chiasma Crashes on FDA Drug Rejection of Mycapssa 4/18/2016
Shire (SHPG) Submits NDA To FDA For New Formulation Of Vyvanse (Lisdexamfetamine Dimesylate) CII As Chewable Tablets 4/14/2016
FDA Accepts For Priority Review Bristol-Myers Squibb (BMY)’s Supplemental Biologics License Application For Opdivo (Nivolumab) For The Treatment Of Classical Hodgkin Lymphoma Patients 4/14/2016
Clovis Oncology (CLVS) Takes Another Hit After An FDA Panel Votes Against Rociletinib 4/14/2016
DURECT (DRRX) Announces FDA Acceptance Of REMOXY NDA, PDUFA Date Of September 25, 2016 4/13/2016
Vernalis PLC (VNLPY.PK) Announces Successful Completion Of CCP-08 Pivotal Single-Dose Comparative Bioavailability Study 4/13/2016
Merck & Co. (MRK) Announces FDA Acceptance Of Biologics License Application for Investigational House Dust Mite Sublingual Allergy Immunotherapy Tablet 4/13/2016
Merck & Co. (MRK) Release: FDA Accepts Supplemental Biologics License Application (sBLA) For KEYTRUDA (Pembrolizumab) In Recurrent Or Metastatic Head And Neck Cancer, And Grants Priority Review 4/13/2016
Bio Products Laboratory Announces FDA Submission Of Biologics License Supplement For Gammaplex 10% 4/13/2016
Clovis Oncology (CLVS)'s Lung Cancer Failure Pain Could be AstraZeneca PLC (AZN)'s Gain 4/13/2016
FDA Accepts Genentech (RHHBY)'s BLA and Grants Priority Review for Lung Cancer Drug Atezolizumab 4/12/2016
FDA Panel Unanimously Backs Speedy Approval of Intercept Pharma (ICPT)'s Liver Disease Drug Ocaliva 4/11/2016
Vectura (VEC.L) Release: VR315 U.S. ANDA For Generic Advair Diskus Accepted For Filing By FDA And Milestone Payment 4/8/2016
FDA Staff Questions Efficacy and Safety Issues of Clovis Oncology (CLVS)'s Lung Cancer Drug 4/8/2016
Biofrontera AG Announces NDA Progress Update For BF-200 ALA 4/5/2016
ConforMIS Withdraws Application as the FDA Raises Questions on iTotal Hip 4/4/2016
FDA Extends Action Date for Progenics (PGNX), Valeant (VRX)'s NDA for Oral RELISTOR 4/4/2016
Lexicon Pharma (LXRX) Submits New Drug Application To FDA For Telotristat Etiprate For The Treatment Of Carcinoid Syndrome 3/31/2016
Dynavax (DVAX) Announces FDA Acceptance For Review Of Biologics License Application And PDUFA Action Date For HEPLISAV-B 3/31/2016
Gilead (GILD) Submits New Drug Application To Japan’s Pharmaceutical And Medical Devices Agency For Tenofovir Alafenamide (TAF) For Patients With Chronic Hepatitis B Infection 3/31/2016
Acadia (ACAD) Surges as FDA Panel Backs Psychosis Drug Linked to Parkinson’s Disease 3/30/2016
Opko Health (OPK) Falls as the FDA Halts Approval of Rayaldee 3/30/2016
Shionogi Submits New Drug Applications In Japan And The U.S. For Naldemedine For The Treatment Of Opioid-Induced Constipation 3/30/2016
FDA Wants Additional Evaluation of Newron Pharma (NWRN)'s Xadago 3/30/2016
SoCal's Puma Biotech (PBYI) Delays NDA for Neratinib to Treat Breast Cancer Until Mid-2016 3/29/2016
H. Lundbeck A/S (LUN.CO) Falls After FDA Rejects Brintellix Label Expansion 3/29/2016
FDA Approves Supplemental New Drug Application (sNDA) For Boehringer Ingelheim's STIOLTO RESPIMAT For COPD Health-Related Quality Of Life 3/29/2016
DURECT Corporation (DRRX) Announces Resubmission Of REMOXY New Drug Application To The FDA 3/29/2016
7 Potential Blockbuster Drugs May Hit the Market This Year 3/28/2016
Aralez Announces FDA Acceptance Of New Drug Application For YOSPRALA 3/28/2016
FDA Staff Says Acadia (ACAD)'s Drug for Parkinson's Disease Psychosis Nuplazid is Effective 3/28/2016
Aratana Therapeutics (PETX) Files For Second FDA Approval 3/23/2016
36 DMD Experts Send Letter to the FDA Urging Approval of Sarepta (SRPT)’s Drug 3/22/2016
Raptor (RPTP)’s PROCYSBI New Drug Submission Accepted By Health Canada With Priority Review 3/22/2016
Anacor (ANAC) Announces FDA Acceptance Of NDA For Crisaborole Topical Ointment, 2% For The Treatment Of Mild-To-Moderate Atopic Dermatitis 3/22/2016
Eagle Pharma (EGRX) Plunges as the FDA Rejects Blood Thinner Kangio 3/18/2016
Elite Pharma (ELI) Announces U.S. FDA Priority Review Designation For Sequestox NDA 3/17/2016
Allergan (AGN) Confirms Generic Abraxane Patent Challenge 3/17/2016
Genentech (RHHBY)'s Bladder Cancer Drug Gains Priority Review by the FDA 3/16/2016
Kindred Bio (KIN) Submits Final Major New Animal Drug Application Technical Section For Safety For Zimeta To FDA 3/16/2016
FDA Panel Backs Abbott (ABT)'s Dissolving Stent 3/16/2016
Aralez Resubmits To FDA New Drug Application For YOSPRALA 3/15/2016
Aeglea Announces FDA Acceptance Of Its Investigational New Drug Application For AEB1102 For The Treatment Of Hematological Malignancies 3/15/2016
Five Companies Face Big FDA Decisions This Month 3/14/2016
FDA Wants TSO3 (TOS) to Evaluate Claims Based on the Type and Manufacture of Device 3/14/2016
Tesaro (TSRO) Submits New Drug Application For Intravenous Rolapitant To The U.S. FDA 3/14/2016
Sarepta (SRPT) Finally Gets Another Date with the FDA for DMD Drug 3/11/2016
FDA Accepts Amgen (AMGN)'s Supplemental Biologics License Application For The Expanded Use Of Enbrel (Etanercept) To Treat Pediatric Patients With Chronic Severe Plaque Psoriasis 3/11/2016
Three Drugmakers Facing FDA Decisions This Quarter 3/10/2016
Telesta (TSX:TST) Requests Meeting With FDA Over Bladder Cancer Drug, Slashes Jobs by 15% 3/9/2016
Celgene (CELG) Notified Of ANDA Filing For ABRAXANE 3/8/2016
PharmaEngine, Inc. Announces Taiwan FDA Granting The Product License Of ONIVYDE (Irinotecan Liposome Injection) For The Treatment Of Metastatic Pancreatic Cancer 3/7/2016
Vericel (ASTM) Announces FDA Acceptance For Filing Of BLA For MACI For The Treatment Of Symptomatic Cartilage Defects In The Knee 3/7/2016
Merck & Co. (MRK) Release: FDA Accepts Supplemental Biologics License Application (Sbla) For KEYTRUDA (Pembrolizumab) In Advanced Non-Small Cell Lung Cancer 3/7/2016
Heron (HRTX)'s Sustol Finally Gets a Date with the FDA 3/3/2016
Amgen (AMGN) Submits Supplemental Biologics License Application For BLINCYTO (Blinatumomab) 3/2/2016
FDA Files Genentech (RHHBY)'s Supplemental Biologics License Application Of Xolair (Omalizumab) For Pediatric Allergic Asthma 3/1/2016
FDA Needs More Time, Delays Assigning Action Date for Heron (HRTX)'s SUSTOL NDA 2/29/2016
Allergan (AGN) Announces Receipt Of FDA Acceptable For Filing Letter For Generic XIFAXAN ANDA 2/29/2016
Egalet Announces FDA Acceptance Of New Drug Application For ARYMO ER (Morphine Sulfate) Extended-Release Tablets 2/29/2016
Baxalta (BXLT) Announces Submission Of Supplemental BLAs To Expand Use Of ADYNOVATE To Pediatric Patients And Surgical Settings 2/26/2016
Allergan (AGN) Release: FDA Accepts And Grants Priority Review For AVYCAZ (ceftazidime and avibactam) Supplemental New Drug Application (sNDA) 2/24/2016
FDA Concurs On Clinical Dose For SIGA (SIGA)’s Tecovirimat Antiviral 2/24/2016
Ironwood (IRWD) Announces Filing By Astellas (ALPMY) Of New Drug Application In Japan With Linaclotide For The Treatment Of Adults With IBS-C 2/24/2016
PTC Therapeutics (PTCT) Crashes as It Becomes Fourth Company to Be Turned Down this Year by FDA for DMD Drug 2/24/2016
Aratana Therapeutics (PETX) Receives Technical Section Complete Letter For Effectiveness For AT-002 2/23/2016
Astellas (ALPMY) Release: FDA Accepts For Review Supplemental New Drug Application For XTANDI (Enzalutamide) Capsules In Metastatic Castration-Resistant Prostate Cancer With Data From Head-To-Head Studies Of Enzalutamide Versus Bicalutamide 2/23/2016
Three Biotechs Cited as Promising Bets in 2016 With FDA Decisions Pending 2/22/2016
FDA Needs More Time to Review Titan Pharma (TTP)' Probuphine NDA 2/22/2016
Neurelis Finalizes Series A Financing To Advance Lead Program To NDA Filing 2/22/2016
Bracco Diagnostics Receives Second U.S. FDA Approval For Barium-Based Products, The First In Computed Tomography 2/22/2016
FDA Accepts Sanofi (SNY) New Drug Application For Once-Daily Fixed-Ratio Combination Of Insulin Glargine And Lixisenatide 2/22/2016
Aratana Therapeutics (PETX) Receives Technical Section Complete Letter For Effectiveness For AT-003 2/22/2016
Zealand Pharma  (ZEAL.CO) Announces That Sanofi (SNY)s NDA For The Fixed-Ratio Combination (Lixilan) Of Lixisenatide And Insulin Glargine For Type 2 Diabetes Has Been Accepted For Review By The FDA 2/22/2016
United Therapeutics (UTHR) Receives Paragraph IV Notice Letter For Orenitram 2/19/2016
Spectrum Pharma (SPPI) Announces FDA’s Acceptance Of NDA Filing For Eoquin (Apaziquone For Intravesical Instillation) 2/19/2016
Mylan (MYL)'s ANDA For Generic Advair Diskus Accepted For Filing By FDA 2/18/2016
Catalyst Pharmaceuticals (CPRX) Tanks on FDA Refuse-to-File Letter 2/18/2016
Portola (PTLA) Announces Biologics License Application For Andexanet Alfa Accepted For Review By FDA 2/18/2016
FDA Spurns Merck & Co. (MRK)'s Cardiovascular Claims for Zetia, Vytorin 2/17/2016
IMPAX Labs (IPXL) Receives FDA Approval For Generic Version Of Adderall XR (Mixed Salts Of A Single-Entity amphetamine product) Capsules, CII 2/17/2016
Cipher Pharma (DND.TO) Announces Sitavig Accepted For Review By Health Canada 2/16/2016
Allergan (AGN) Release: FDA Accepts Supplemental New Drug Application (sNDA) For TEFLARO (ceftaroline fosamil) 2/16/2016
Kindred Bio (KIN) Submits Zimeta (KIND-012) New Animal Drug Application Technical Section For Effectiveness To FDA 2/12/2016
Clovis Oncology (CLVS) Announces Rociletinib New Drug Application Scheduled For Presentation At Upcoming FDA Oncologic Drugs Advisory Committee Meeting 2/12/2016
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
FDA 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
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
FDA Spurns Vertex (VRTX) Application for Expanded Use of Kalydeco 2/5/2016
FDA Acknowledges Receipt Of Resubmission Of Shire (SHPG)'s New Drug Application For Lifitegrast For Dry Eye Disease In Adults 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



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