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Clinical - BLA/NDA/ANDA
UCB Release: Company Files BRIVIACT (Brivaracetam) CV In The U.S. As Monotherapy Treatment For Adult Epilepsy Patients With Partial-Onset Seizures 1/20/2017
Adamis (ADMP) Release: Company Announces NDA Resubmission Of Its Epinephrine Pre-Filled Syringe Application To The FDA 1/19/2017
Symbiomix Release: Pharma Submits New Drug Application To US FDA For Solosec For The Treatment Of BV 1/19/2017
Shire (SHPG) Release: FDA Acknowledges Receipt Of The Company's NDA For ADHD Drug 1/19/2017
EZRA Innovations Release: Company Announces FDA Acceptance Of Filing Of New Drug Application For EZR-104 For The Treatment Of Hypertension And Heart Failure 1/19/2017
Boehringer Ingelheim Release: Company's Biosimilar Candidate To Humira® Accepted For EMA And FDA Regulatory Review 1/18/2017
Eli Lilly (LLY)-Incyte (INCY) Release: The FDA Wants More Time to Review Baricitinib 1/16/2017
Tesaro (TSRO) Craters as the FDA Denies Approval of Rolapitant IV 1/13/2017
Heron (HRTX) Release: Biotech Announces Submission Of CINVANTI NDA For The Prevention Of Chemotherapy-Induced Nausea And Vomiting (CINV) 1/12/2017
JPM17: Kite Pharma (KITE)'s Strategy for Commercializing Its Lead CAR-T Drug 1/12/2017
Mylan (MYL) Release: FDA Accepts Biologics License Application (BLA) For Pharma And BioCon (BIOCON.NS)'s Proposed Biosimilar Trastuzumab 1/11/2017
Merck & Co. (MRK) Release: Company Receives FDA Acceptance Of Supplemental Biologics License Application For KEYTRUDA (Pembrolizumab) In Combination With Chemotherapy For First-Line Treatment Of Metastatic Non-Squamous Non-Small Cell Lung Cancer 1/11/2017
MabVax Therapeutics Files Investigational New Drug Application For Novel Radioimmunotherapy Agent MVT-1075 1/9/2017
Advanced Accelerator Applications CEO Provides Progress Report On Corporate Developments Of 2016; Asserts Confidence In Ability To Address FDA Comments On Lutathera NDA 1/9/2017
Genentech (RHHBY)’s Bladder Cancer Drug Wins Priority Review From the FDA 1/9/2017
AcelRx (ACRX) Provides Guidance On 2017 Milestones For ARX-04, Now Known As DSUVIA In The United States, For The Treatment Of Moderate-To-Severe Acute Pain 1/9/2017
AcelRx (ACRX) Announces DSUVIA As Brand Name For ARX-04 In The United States 1/9/2017
HEMA Biologics Announced Today The Acceptance By FDA Of The Submitted Biologic License Application For Coagulation Factor Viia Recombinant, (Eptacog Beta Activated) 1/9/2017
IMPAX Labs (IPXL) Confirms Patent Challenge Relating To Generic Aubagio (Teriflunomide) Tablets, 14 Mg 1/6/2017
Neurocrine Biosciences (NBIX) Provides Update On FDA Advisory Committee For INGREZZA (Valbenazine) For The Treatment Of Tardive Dyskinesia 1/6/2017
Adamas Pharma (ADMS) Announces U.S. FDA Acceptance Of ADS-5102 New Drug Application For The Treatment Of Levodopa-Induced Dyskinesia In Patients With Parkinson's Disease 1/6/2017
KaloBios (KBIO) Announces Positive Guidance From FDA For Benznidazole 1/6/2017
LFB S.A. Announced Today The Acceptance By U.S. FDA Of The Filed Biologic License Application For Coagulation Factor VIIa Recombinant, (Eptacog Beta Activated) 1/6/2017
Eli Lilly (LLY) Release: U.S. FDA Approves Supplemental New Drug Applications To Include Landmark Data In Product Labels For Synjardy (Empagliflozin/Metformin Hydrochloride), Synjardy XR (Empagliflozin/Metformin Hydrochloride Extended-Release) And Glyxambi (Empagliflozin/Linagliptin) Tablets 1/5/2017
Melinta New Drug Application For Baxdela Accepted For Filing By FDA 1/5/2017
Keystone Nano Announces FDA Approval Of Investigational New Drug Application For Ceramide NanoLiposome For The Improved Treatment Of Cancer 1/5/2017
Ironwood (IRWD) Announces New Drug Application For DUZALLO (Fixed-Dose Combination Of Lesinurad And Allopurinol) Has Been Accepted For FDA Review 1/4/2017
Allergan (AGN) Release: FDA Accepts For Filing Supplemental New Drug Application (sNDA) For LILETTA (Levonorgestrel-Releasing Intrauterine System) 52 Mg 1/4/2017
Custopharm Acquires Two ANDA Pharmaceutical Products From Perrigo (PRGO) 1/4/2017
FDA Grants Bayer (BAY) Priority Review For Stivarga (Regorafenib) For The Second-Line Systemic Treatment Of Liver Cancer 1/4/2017
7 Biotech Companies With Key FDA Decisions or Catalysts in January and February 2017 1/3/2017
Eagle Pharma (EGRX)’ Pemetrexed NDA Submitted For Review 1/3/2017
Innocoll (INNL) Shares Tumble After FDA's Refusal to File Xaracoll NDA 12/30/2016
FDA Rejects Cempra (CEMP)'s NDAs for Solithromycin, Shares Sink 12/30/2016
CFDA Accepts NDA For Hepatitis C Drug From Ascletis 12/29/2016
Why Did New Drug Approvals In The U.S. Plunge This Year? 12/27/2016
Portola (PTLA) Announces FDA Accepts New Drug Application For Priority Review And EMA Validates Marketing Authorization Application For Oral, Factor Xa Inhibitor Anticoagulant Betrixaban 12/27/2016
Another Delay, Aerie (AERI) Now Expects to Resubmit Rhopressa NDA Filing in Q1 2017 12/27/2016
GenMark Diagnostics (GNMK) Submits 510(K) Applications To The FDA For ePlex Sample-To-Answer Instrument And Respiratory Pathogen Panel 12/22/2016
Elite Pharma (ELI) Provides Update on SequestOx New Drug Application 12/22/2016
Janssen Biotech (JNJ) Submits Two Applications To FDA Seeking Approval Of SIMPONI ARIA (Golimumab) For The Treatment Of Active Psoriatic Arthritis And Active Ankylosing Spondylitis 12/21/2016
Antares Pharma (ATRS) Announces Submission Of New Drug Application For Quickshot Testosterone 12/21/2016
Genentech (RHHBY) Release: FDA Extends Review Of Application For OCREVUS (Ocrelizumab) 12/21/2016
FDA Accepts Supplemental New Drug Application For Pfizer (PFE)’s IBRANCE (Palbociclib) In HR+, HER2- Metastatic Breast Cancer 12/21/2016
Tris Pharma, Inc. Release: FDA Accepts CCP-08 NDA For Full Review 12/21/2016
Tesaro (TSRO) Announces Priority Review Designation For Niraparib NDA 12/20/2016
Amgen (AMGN) And UCB, Inc. (UCBJF.PK) Announce Submission Of Application For Investigational Osteoporosis Medication Romosozumab In Japan 12/20/2016
Neos Therapeutics (NEOS) Completes Resubmission Of NDA For Cotempla XR-ODT For The Treatment Of ADHD 12/20/2016
Samsung Bioepis’ Type II Variation Application For Indication Extension Of Benepali Receives Positive CHMP Opinion 12/19/2016
Lannett (LCI) Announces Supplemental Approval For Morphine Sulfate Oral Solution CII, 20 Mg/Ml 12/19/2016
ProMetic Life Sci (PFSCF.PK) Initiates Rolling Submission Of Its Biologics License Application ("BLA") For Plasminogen With U.S. FDA 12/19/2016
Evoke Pharma (EVOK) Receives Positive NDA Submission Guidance From U.S. FDA For Gimoti 12/19/2016
AbbVie (ABBV) Submits New Drug Application To U.S. FDA For Its Investigational Regimen Of Glecaprevir/Pibrentasvir (G/P) For The Treatment Of All Major Genotypes Of Chronic Hepatitis C 12/19/2016
Janssen Biotech (JNJ) Submits Application Seeking FDA Approval Of STELARA (Ustekinumab) For The Treatment Of Adolescents With Moderate To Severe Plaque Psoriasis 12/16/2016
Amgen (AMGN) Release: New Repatha (evolocumab) Dose Delivery Option Receives Positive CHMP Opinion 12/16/2016
CHMP Recommends Approval Of Eli Lilly (LLY)'s Baricitinib For The Treatment Of Adults With Moderate To Severe Active Rheumatoid Arthritis (RA) 12/16/2016
Adamis (ADMP) Announces NDA Resubmission Of Its Epinephrine Pre-Filled Syringe Application To The FDA 12/16/2016
Boehringer Ingelheim Release: CHMP Adopts A Positive Opinion Acknowledging That Jardiance Reduces The Risk Of CV Death 12/16/2016
EMA’s CHMP Recommends Merck & Co. (MRK)’s KEYTRUDA (Pembrolizumab) For The First-Line Treatment Of Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) Whose Tumors Have High PD-L1 Expression With No EGFR Or ALK Positive Tumor Mutations 12/16/2016
Ironshore Pharma Announces FDA Acceptance Of HLD200 New Drug Application For Treatment Of ADHD 12/15/2016
Alcobra (ADHD) Updates On Recent FDA Meeting 12/14/2016
Bayer (BAY) Announces FDA Acceptance Of Supplemental Biologics License Application For myBETAapp And BETACONNECT Navigator 12/14/2016
AcelRx (ACRX) Submits New Drug Application For ARX-04 For The Treatment Of Moderate-To-Severe Acute Pain 12/13/2016
Flexion (FLXN) Submits New Drug Application For Zilretta To Treat Knee Osteoarthritis Pain 12/13/2016
Elite Pharma (ELI) Files ANDA For Hydrocodone And Acetaminophen Combo 12/12/2016
KaloBios (KBIO) Completes Meeting With FDA For Benznidazole 12/12/2016
Neurotrophic Keratitis: EMA Validates The Marketing Authorisation Application For Cenegermin Eye Drops (Oxervate) Submitted By Dompe 12/12/2016
Gilead (GILD) Submits New Drug Application To The FDA For The Investigational Single Tablet Regimen Sofosbuvir/Velpatasvir/Voxilaprevir 12/8/2016
Iroko Pharma Provides Update In Relation To Zorvolex 12/7/2016
Kitov (KTOV) Successfully Completes All KIT-302 Testing Required For New Drug Application To U.S. FDA 12/7/2016
Kadmon Submits Abbreviated New Drug Application Filing For Trientine Hydrochloride To FDA 12/6/2016
Novo Nordisk A/S (NVO) Files For Regulatory Approval Of Once-Weekly Semaglutide With The FDA For The Treatment Of Type 2 Diabetes 12/5/2016
CASI Pharma (CASI)' Import Drug Registration Application For EVOMELA Accepted For Review By CFDA 12/5/2016
Kite Pharma (KITE) Initiates Rolling Submission Of U.S. Biologics License Application (BLA) For KTE-C19, Its Investigational Anti-CD19 CAR-T Therapy, For The Treatment Of Patients With Relapsed/Refractory Aggressive B-Cell Non-Hodgkin Lymphoma (NHL) 12/5/2016
Egalet Announces Filing Of Supplemental New Drug Application For OXAYDO To FDA 12/2/2016
FDA Grants Priority Review To Supplemental Biologics License Application (sBLA) For Merck & Co. (MRK)'s KEYTRUDA (Pembrolizumab) In Relapsed Or Refractory Classical Hodgkin Lymphoma 12/1/2016
Teligent Announces FDA Approval Of Clobetasol Propionate Lotion 0.05% 11/30/2016
Lannett (LCI) Provides Update On Methylphenidate ER Tablets 11/30/2016
Neurocrine Biosciences (NBIX) Announces FDA Advisory Committee Meeting To Review INGREZZA (Valbenazine) New Drug Application For The Treatment Of Tardive Dyskinesia 11/30/2016
Otsuka Pharma Release: FDA Accepts For Review A Supplemental New Drug Application To Expand Labeling Of Abilify Maintena (Aripiprazole) For The Treatment Of Bipolar I Disorder 11/30/2016
Amicus (FOLD) Plummets on 3-Year Delay to U.S. Fabry Drug FDA Filing Plan 11/29/2016
Breckenridge Pharmaceutical, Inc. Announces Final ANDA Approval For Armodafinil Tablets (CIV) In 50mg, 150mg And 250 Mg Strengths (Nuvigil) 11/29/2016
EMD Serono Release: FDA Accepts The Biologics License Application For Avelumab For The Treatment Of Metastatic Merkel Cell Carcinoma For Priority Review 11/29/2016
MonoSolRx LLC Submits New Drug Application For Tadalafil PharmFilm 11/29/2016
Lannett (LCI) Announces Approval For Metaxalone Tablets USP, 800 Mg 11/28/2016
Advanced Accelerator Applications Reports 15.4% Sales Growth In The Third Quarter Of 2016 And Feedback From The FDA For Lutathera, An Investigational Treatment For Neuroendocrine Tumors 11/28/2016
Relypsa (RLYP) Release: FDA Approves Supplemental New Drug Application For Veltassa Removing Boxed Warning Regarding Drug-Drug Interactions 11/28/2016
IntelliPharmaCeutics Submits New Drug Application For Rexista® (Oxycodone Hydrochloride Extended Release), An Abuse Deterrent Opioid Analgesic For The Treatment Of Moderate To Severe Pain 11/28/2016
FDA Grants Priority Review To Merck & Co. (MRK)’s Supplemental Biologics License Application (sBLA) Seeking Approval For KEYTRUDA (Pembrolizumab) For New Indication In Microsatellite Instability-High Cancer 11/28/2016
Green Cross Receives Complete Response Letter From US FDA For IVIG-SN 11/23/2016
Theravance Biopharma (TBPH) Highlights Filing Of U.S. New Drug Application For The Closed Triple In COPD By GlaxoSmithKline (GSK) And Innoviva 11/22/2016
Intarcia Submits New Drug Application (NDA) To FDA For U.S. Marketing Approval Of ITCA 650 In Type 2 Diabetes 11/21/2016
GlaxoSmithKline (GSK) Files Regulatory Submission In US For Once-Daily Closed Triple Combination Therapy FF/UMEC/VI For Patients With COPD 11/21/2016
International Isotopes (INIS) Submits Abbreviated New Drug Application For Sodium Iodide I-131 11/21/2016
Apricus Biosciences (APRI) Provides Update On Vitaros NDA Following Receipt Of FDA Feedback 11/18/2016
Spectrum Pharma (SPPI) Plays With a New Phase III Concept After the FDA Formally Spurns Bladder Cancer Drug 11/18/2016
VetDC Files Final TANOVEA FDA Submission For Use In Canine Lymphoma 11/17/2016
Janssen Biotech (JNJ) Submits Application To FDA Seeking Approval Of Anti-Interleukin-23 Monoclonal Antibody Guselkumab For The Treatment Of Moderate To Severe Plaque Psoriasis 11/17/2016
Neos Therapeutics (NEOS) Submits NDA For Amphetamine Extended-Release Liquid Suspension Drug Candidate, NT-0201, For The Treatment Of ADHD 11/17/2016
Genentech (RHHBY) Braces for Competition From Amgen (AMGN)-Allergan (AGN) for Best-Selling Drug Avastin 11/17/2016
MorphoSys AG Announces That Its Licensee Janssen R&D Has Submitted Biologics License Application For Guselkumab 11/17/2016
Amgen (AMGN) And Allergan (AGN) Submit Biosimilar Biologics License Application For ABP 215 To FDA 11/16/2016
Novartis AG (NVS) Drug PKC412 (Midostaurin) Granted FDA Priority Review For Newly-Diagnosed FLT3-Mutated AML And Advanced Systemic Mastocytosis 11/14/2016
Bay Area's Dynavax (DVAX) Plunges After the FDA Spurns HEPLISAV-B Again 11/14/2016
Zealand Pharma  (ZEAL.CO) Release: CHMP Issues Positive Opinion Recommending Suliqua (Iglarlixi) For Approval In The EU 11/11/2016
Kite Pharma (KITE) Pushes Back Timeline Slightly for Filing of Its Pioneering CAR-T Candidate KTE-C19 11/10/2016
Emmaus Life Sciences' New Drug Application For Sickle Cell Disease Accepted For Review By FDA 11/9/2016
Mylan (MYL) And BioCon (BIOCON.NS) Announce U.S. FDA Submission For Proposed Biosimilar Trastuzumab 11/9/2016
Kedrion And Kamada Ltd. (KMDA) Announce FDA Acceptance Of BLA Submission For Human Rabies Immunoglobulin As A Post-Exposure Treatment 11/7/2016
FDA Panel Barely Gives a Pass to Cempra (CEMP)'s Antibiotic Solithromycin 11/7/2016
Bayer (BAY) Submits Supplemental New Drug Application For Stivarga (regorafenib) For Advanced Liver Cancer 11/7/2016
FDA Accepts Genentech (RHHBY)'s Biologics License Application For Subcutaneous Formulation Of Rituximab 11/3/2016
Agios (AGIO) Reports Third Quarter 2016 Financial Results And Reviews Recent Progress In IDH And PKR Development Programs 11/3/2016
Paratek Pharma (PRTK) Reports Third Quarter 2016 Financial Results and Provides Clinical Updates 11/2/2016
Tesaro (TSRO) Announces Submission Of Niraparib New Drug Application For Platinum-Sensitive, Recurrent Ovarian Cancer 11/2/2016
Cempra (CEMP) Plunges After the FDA Cites Liver Issues With Antibiotic 11/2/2016
OUCH! FDA Spurns Regeneron (REGN), Sanofi (SNY)'s RA Drug Over Plant Deficiencies 11/1/2016
Astex Pharma (ASTX) Achieves Milestone On FDA Filing Of New Drug Application (NDA) For LEE011 (Ribociclib) Plus Letrozole As A First-Line Treatment For HR+/HER2- Advanced Breast Cancer 11/1/2016
Deficiencies Found at Manufacturing Site Could Delay Approval of Sanofi Genzyme (SNY)'s Next Blockbuster 10/31/2016
Merrimack (MACK) Announces Acceptance For Review Of ANDA Filed By Actavis For Generic Doxorubicin Hydrochloride Liposome Injection (Aka DOXIL) 10/31/2016
Aclaris (ACRS) Submits Investigational New Drug Application For ATI-50001 To Treat Alopecia Universalis And Alopecia Totalis 10/31/2016
Ariad (ARIA) Announces U.S. FDA Acceptance Of NDA Filing For Brigatinib 10/31/2016
Adamas Pharma (ADMS) Submits New Drug Application To U.S. FDA For ADS-5102 For The Treatment Of Levodopa-Induced Dyskinesia In Patients With Parkinson’s Disease 10/27/2016
Watch Out Juno (JUNO) and Kite Pharma (KITE): Novartis AG (NVS) Clearly Not Done With CAR-T 10/26/2016
Immune Therapeutics Announces Filing Acceptance Of New Drug Applications For Lodonal For The Treatment Of Patients With Human Immuno-Deficiency, Cancer And As An Immune Booster 10/26/2016
Harvard Experts Fret Over the Fallout From FDA’s OK for Sarepta (SRPT)’s Controversial DMD Drug 10/25/2016
Portola (PTLA) Submits New Drug Application To FDA For Betrixaban For Extended Duration Prophylaxis Of Venous Thromboembolism In Acute Medically Ill Patients 10/25/2016
Actinium (ATNM.OB) Initiates Pursuit Of Scientific Advice For Iomab-B From The EMA 10/25/2016
Bristol-Myers Squibb (BMY) Release: FDA Accepts For Priority Review The Supplemental Biologics License Application For Opdivo (Nivolumab) In Previously Treated Patients With Advanced Form Of Bladder Cancer 10/24/2016
Ligand (LGND) Partner Melinta Submits Baxdela New Drug Application For Hospital-Treated Skin Infections 10/24/2016
GlaxoSmithKline (GSK) Seeks FDA Green Light for Its Potential $1 Billion Shingles Vaccine 10/24/2016
China Spurns 30 Drug Apps Due to Fudged Data 10/24/2016
2 Biotechs Face Key Decisions in Mid-Fourth Quarter 10/21/2016
Allergan (AGN) Release: FDA Advisory Committee Recommends Approval Of SER120 (Desmopressin Nasal Spray) 10/21/2016
Astellas (ALPMY) Release: FDA Approves Supplemental New Drug Application For XTANDI (Enzalutamide) Capsules In Advanced Prostate Cancer 10/21/2016
U.S. FDA Considers Newron Pharma (NWRN)'s Re-Submitted NDA For Xadago To Be A Complete, Class 2 Response To Complete Response Letter 10/21/2016
How Fast Can Kite Pharma (KITE) File for an Approval of its Lead CAR-T? 10/20/2016
Teva (TEVA) Announces FDA Acceptance Of Resubmitted New Drug Application For SD-809 For Treatment Of Chorea Associated With Huntington Disease 10/20/2016
Advanced Accelerator Applications Announces Positive EMA Opinion On Application For Somakit TOC 10/17/2016
Lipocine (LPCN) Completes Post Action Meeting With FDA For LPCN 1021 New Drug Application 10/17/2016
PTC Therapeutics (PTCT) Tanks After the FDA Denies DMD Drug Translarna Again 10/17/2016
3 Biotechs With Cancer Drugs That Could Win Approval in 2017 10/14/2016
The FDA Won't Meet PDUFA Goal Date For Egalet's ARYMO ER 10/14/2016
FDA, Clinuvel To Discuss SCENESSE At Pre-NDA Meeting 10/13/2016
Sunovion Announces FDA Filing Acceptance Of New Drug Application For SUN-101/Eflow For The Treatment Of Patients With Chronic Obstructive Pulmonary Disease (COPD) 10/13/2016
Alexza Pharma (ALXA) Announces U.S. Approval Of ADASUVE sNDA 10/11/2016
Neurocrine Biosciences (NBIX) Announces INGREZZA (Valbenazine) New Drug Application For The Treatment Of Tardive Dyskinesia Has Been Accepted For Priority Review By U.S. FDA 10/11/2016
Allergan (AGN) Release: FDA Accepts Supplemental New Drug Application (sNDA) For AVYCAZ (Ceftazidime And Avibactam) 10/11/2016
FDA Bestows Priority Review to Genentech (RHHBY)’s Lucentis sBLA for mCNV 10/11/2016
PetLife Pharma Is Pleased To Showcase Its New “Vitalzul™ Information Video” Along With A Corporate Update 10/10/2016
IntelliPharmaCeutics Announces FDA Tentative Approval for Generic Seroquel XR 10/10/2016
PTC Therapeutics (PTCT) Wants a Slice of Sarepta (SRPT)'s DMD Pie, Says Rejected Drug May Help Some Patients 10/7/2016
Repros Therapeutics (RPRX) Announces Acceptance Of Dossier For Enclomiphene For Secondary Hypogonadism By European Authorities 10/6/2016
Collegium (COLL) Submits Supplemental New Drug Submission To FDA For Xtampza ER 10/5/2016
Kindred Bio (KIN) Receives Approval Of Effectiveness Technical Section From FDA For Zimeta New Animal Drug Application 10/5/2016
Jazz Pharma (JAZZ) Initiates Rolling NDA Submission For Vyxeos (CPX-351) Expects To Complete NDA Submission By Early 2017 10/3/2016
Collegium (COLL) Submits New Drug Submission To Health Canada or Xtampza ER, An Analgesic With Abuse-Deterrent Properties For The Treatment Of Chronic Pain 10/3/2016
TRACON Pharma (TCON) Announces Successful Meetings With FDA And EMA For TRC105 (Carotuximab) In Angiosarcoma 10/3/2016
BioPharm Executive: Did the FDA Just Destroy Its Credibility? 10/3/2016
Kindred Bio (KIN) Submits Final Major New Animal Drug Application Technical Section For Safety For Mirataz To FDA And Launches KindredBio Equine Website 9/30/2016
ARK Animal Health, A Subsidiary Of Sorrento (SRNE), Announces Submission Of Two Major Technical Sections Of A New Animal Drug Application 9/27/2016
ResQ Pharma Raises $725,000 And Scheduled To Meet FDA September 29th 2016 9/27/2016
Eisai Inc. (ESALF.PK) Submits Supplemental Application To FDA For Use Of Its Antiepileptic Drug FYCOMPA (Perampanel) As Monotherapy For The Treatment Of Partial Onset Seizures 9/27/2016
Amgen (AMGN) And UCB Group (UCBJF.PK) Announce U.S. FDA Acceptance Of Biologics License Application For Romosozumab 9/27/2016
For Pain Therapeutics (PTIE) CEO, 3 FDA Rejections Are Worth $23 Million 9/27/2016
FDA Set to Decide on Two Likely Blockbuster Drugs By Sanofi Genzyme (SNY) 9/26/2016
AbbVie (ABBV) Announces Submission Of A Supplemental New Drug Application For Ibrutinib (IMBRUVICA) For Treatment Of Marginal Zone Lymphoma 9/26/2016
DURECT (DRRX)'s Licensee Pain Therapeutics (PTIE) Receives Complete Response Letter From FDA For REMOXY ER (Oxycodone) Extended-Release Capsules CII 9/26/2016
Regeneron (REGN) And Sanofi (SNY) Announce Dupilumab Biologics License Application Accepted For Priority Review By U.S. FDA 9/26/2016
Repros Therapeutics (RPRX) Release: FDA Schedules Advisory Committee Meeting To Discuss Secondary Hypogonadism 9/26/2016
Janssen Pharmaceutical Companies Release: Ibrutinib (IMBRUVICA) Supplemental New Drug Application Submitted To The FDA For Marginal Zone Lymphoma (MZL) 9/26/2016
FDA Slaps Down Pain Therapeutics (PTIE)'s Remoxy for the Third Time, Stock Plummets 9/26/2016
Biogen (BIIB) Completes Rolling Submission Of New Drug Application To FDA For Nusinersen As A Treatment For Spinal Muscular Atrophy 9/26/2016
Janssen Biotech (JNJ) Submits Application Seeking Approval Of Sirukumab In United States For Rheumatoid Arthritis 9/23/2016
Newron Pharma (NWRN) Re-submits U.S. NDA For Xadago (Safinamide) 9/22/2016
Lannett (LCI) Announces Approval For Buprenorphine And Naloxone Sublingual Tablets, 2 mg/0.5 mg And 8 mg/2 mg 9/20/2016
Advanced Accelerator Applications Announces Revised EMA Review Timeline For Lutathera 9/20/2016
Puma Biotech (PBYI) Announces FDA Acceptance Of New Drug Application For PB272 (Neratinib) For Extended Adjuvant Treatment Of HER2-Positive Early Stage Breast Cancer 9/20/2016
TherapeuticsMD (TXMD) Announces FDA Acceptance Of New Drug Application (NDA) And Prescription Drug User Fee Act (PDUFA) Date For Yuvvexy (TX-004HR) 9/20/2016
Spectrum Pharma (SPPI) Allegedly Hid a Key Detail From a Meeting With the FDA 9/19/2016
Intercept Pharma (ICPT) Files New Drug Submission To Health Canada For Marketing Approval Of Obeticholic Acid For The Treatment Of Patients With Primary Biliary Cholangitis 9/19/2016
Sarepta (SRPT) Announces FDA Accelerated Approval Of EXONDYS 51 (Eteplirsen) Injection, An Exon Skipping Therapy To Treat Duchenne Muscular Dystrophy (DMD) Patients Amenable To Skipping Exon 51 9/19/2016
Boehringer Ingelheim And Eli Lilly (LLY) Release: Glyxambi (Empagliflozin/Linagliptin) Approval Recommended By CHMP For Adults With Type 2 Diabetes In The European Union 9/16/2016
Navidea (NAVB)’s Lymphoseek Receives Positive Opinion In Europe For A New Reduced Mass Vial 9/16/2016
Intarcia Completes First Close Of A Major Equity Financing; Poised For ITCA 650 NDA Filing For Type 2 Diabetes, Commercial Readiness And Pipeline Progression 9/15/2016
Turn the Page: Sarepta (SRPT) Stock Pops on Rumors DMD Drug Naysayer Leaves the FDA 9/15/2016
FDA Panel Votes Against Spectrum Pharma (SPPI)'s Bladder Cancer Drug 9/14/2016
10 Biotechs—Count ‘Em, 10!—With Big Decisions in the Fourth Quarter 9/13/2016
Clovis Oncology (CLVS) Stock Jumps as FDA Skips Review Panel for New Cancer Drug 9/12/2016
Another Celgene (CELG) Bet Pays Off as Agios (AGIO) Eyes Early Approval of Leukemia Drug 9/8/2016
FDA Berates Celator Pharma (CPXX) for Pushing Unapproved Leukemia Drug to Doctors 9/8/2016
Emmaus Life Sciences Submits New Drug Application For Sickle Cell Disease Treatment 9/8/2016
FDA Grants Priority Review and Breakthrough Tag for Merck & Co. (MRK)’s Keytruda 9/7/2016
Aerie (AERI) Submits New Drug Application To U.S. FDA For Rhopressa (Netarsudil Ophthalmic Solution) 0.02% 9/7/2016
September is a Busy Month for 7 Biotechs 9/6/2016
Vernalis PLC (VNLPY.PK) Release: FDA Accepts CCP-07 NDA For Full Review 9/6/2016
Bay Area's Dynavax (DVAX) Plummeted After the FDA Cancels Advisory Meeting 9/6/2016
More Trouble for Theranos as FDA Discovers Company Cut Corners With Zika Test 9/1/2016
Array BioPharma (ARRY) Announces FDA Acceptance Of Binimetinib NDA For Patients With Advanced NRAS-Mutant Melanoma 9/1/2016
Kamada Ltd. (KMDA) And Kedrion Seek FDA Approval Of Human Rabies Immunoglobulin As A Post-Exposure Treatment 9/1/2016