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Clinical - BLA/NDA/ANDA
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
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
Lannett (LCI) Provides Update On Methylphenidate ER Tablets 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
MonoSolRx LLC Submits New Drug Application For Tadalafil PharmFilm 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
Lannett (LCI) Announces Approval For Metaxalone Tablets USP, 800 Mg 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
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
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
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
Spectrum Pharma (SPPI) Plays With a New Phase III Concept After the FDA Formally Spurns Bladder Cancer Drug 11/18/2016
Apricus Biosciences (APRI) Provides Update On Vitaros NDA Following Receipt Of FDA Feedback 11/18/2016
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
VetDC Files Final TANOVEA FDA Submission For Use In Canine Lymphoma 11/17/2016
Amgen (AMGN) And Allergan (AGN) Submit Biosimilar Biologics License Application For ABP 215 To FDA 11/16/2016
Bay Area's Dynavax (DVAX) Plunges After the FDA Spurns HEPLISAV-B Again 11/14/2016
Novartis AG (NVS) Drug PKC412 (Midostaurin) Granted FDA Priority Review For Newly-Diagnosed FLT3-Mutated AML And Advanced Systemic Mastocytosis 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
FDA Panel Barely Gives a Pass to Cempra (CEMP)'s Antibiotic Solithromycin 11/7/2016
Kedrion And Kamada Ltd. (KMDA) Announce FDA Acceptance Of BLA Submission For Human Rabies Immunoglobulin As A Post-Exposure Treatment 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
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
Paratek Pharma (PRTK) Reports Third Quarter 2016 Financial Results and Provides Clinical Updates 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
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
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
2 Biotechs Face Key Decisions in Mid-Fourth Quarter 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
Allergan (AGN) Release: FDA Advisory Committee Recommends Approval Of SER120 (Desmopressin Nasal Spray) 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
PTC Therapeutics (PTCT) Tanks After the FDA Denies DMD Drug Translarna Again 10/17/2016
Lipocine (LPCN) Completes Post Action Meeting With FDA For LPCN 1021 New Drug Application 10/17/2016
Advanced Accelerator Applications Announces Positive EMA Opinion On Application For Somakit TOC 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
FDA Bestows Priority Review to Genentech (RHHBY)’s Lucentis sBLA for mCNV 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
IntelliPharmaCeutics Announces FDA Tentative Approval for Generic Seroquel XR 10/10/2016
PetLife Pharma Is Pleased To Showcase Its New “Vitalzul™ Information Video” Along With A Corporate Update 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
BioPharm Executive: Did the FDA Just Destroy Its Credibility? 10/3/2016
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
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
For Pain Therapeutics (PTIE) CEO, 3 FDA Rejections Are Worth $23 Million 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
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
FDA Slaps Down Pain Therapeutics (PTIE)'s Remoxy for the Third Time, Stock Plummets 9/26/2016
FDA Set to Decide on Two Likely Blockbuster Drugs By Sanofi Genzyme (SNY) 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
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
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
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
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
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
Turn the Page: Sarepta (SRPT) Stock Pops on Rumors DMD Drug Naysayer Leaves the FDA 9/15/2016
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
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
Bay Area's Dynavax (DVAX) Plummeted After the FDA Cancels Advisory Meeting 9/6/2016
Vernalis PLC (VNLPY.PK) Release: FDA Accepts CCP-07 NDA For Full Review 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
Neurocrine Biosciences (NBIX) Announces FDA Conditional Acceptance Of Proprietary Name INGREZZA For VMAT2 Inhibitor Valbenazine 9/1/2016
Perrigo (PRGO) Announces Tentative FDA Approval For Generic Version Of Epiduo Gel 9/1/2016
Medimetriks Pharmaceuticals, Inc.' New Drug Application For Ozenoxacin Cream, 1% Accepted For Review By FDA 8/31/2016
Neurocrine Biosciences (NBIX) Submits New Drug Application For Valbenazine For Treatment Of Tardive Dyskinesia 8/30/2016
FDA Accepts Mitsubishi Tanabe's NDA Filing For Edaravone To Treat ALS 8/30/2016
FDA Accepts CSL Behring's Biologics License Application For First Subcutaneous Prophylactic Therapy To Prevent Hereditary Angioedema Attacks 8/30/2016
Ariad (ARIA) Completes Rolling Submission Of New Drug Application For Brigatinib To The FDA 8/30/2016
Vanda (VNDA) Investors Elated Over Drug Patent Ruling 8/26/2016
Amgen (AMGN) Remains Hush-Hush Over FDA Rejection of Parsabiv 8/25/2016
Clovis Oncology (CLVS) Rockets as FDA Agrees to Priority Review of Rucaparib NDA 8/25/2016
Teligent Announces Health Canada Approval Of Three Baclofen Injection Products 8/25/2016
Teligent Announces Health Canada Approval Of Gentamicin Injection USP 8/23/2016
Kindred Bio (KIN) Submits New Animal Drug Application Technical Section For Effectiveness For Mirataz To FDA 8/23/2016
Sanofi (SNY) Loses Lead on New Diabetes Drug After FDA Delay 8/22/2016
Supernus Pharmaceuticals (SUPN) Receives FDA Tentative Approval For Expanded Label Of Trokendi XR To Include Migraine Prophylaxis In Adults 8/22/2016
Emmaus Life Sciences to Seek Marketing Approval for First New Sickle Cell Disease Treatment in Nearly 20 Years; Expects to Submit New Drug Application to FDA in September 8/22/2016
Sarepta (SRPT)’s Duchene Muscular Dystrophy Drug: Evaluating the Placebo Effect 8/19/2016
Bay Area's Portola (PTLA) Plummets as FDA Rejects AndexXa NDA 8/19/2016
Janssen Biotech (JNJ) Submits Application To U.S. FDA To Expand Indication For Daratumumab (DARZALEX) 8/18/2016
Amerigen Pharmaceuticals Announces Final Approval From FDA For Generic Version Of Temodar 8/18/2016
Endo International (ENDP) Withdraws Its Supplemental NDA for Pain Drug OPANA 8/12/2016
Elite Pharma (ELI) Files ANDA To Market Generic Percoce 8/10/2016
FDA Accepts Marathon Pharma’ New Drug Applications For Deflazacort For The Treatment Of Duchenne Muscular Dystrophy And Grants Priority Review 8/10/2016
Eagle Pharma (EGRX) Reports Positive Outcome From FDA Meeting For RYANODEX For Exertional Heat Stroke NDA Submission 8/9/2016
Alkermes (ALKS) Submits Supplemental New Drug Application To FDA For Two-Month Dosing Option Of ARISTADA For Treatment Of Schizophrenia 8/8/2016
Dynavax (DVAX) Announces FDA Advisory Committee Meeting To Review HEPLISAV-B 8/8/2016
Merck & Co. (MRK) Announces FDA Filing Acceptance Of New Drug Application (NDA) For MK-1293, An Investigational Follow-On Biologic Insulin Glargine 8/5/2016
Egalet Announces FDA Advisory Committees Recommend Approval of Abuse-Deterrent ARYMO ER (Morphine Sulfate) and Reports Second Quarter 2016 Financial Results 8/5/2016
Ocular Therapeutix (OCUL) Provides Update On NDA For DEXTENZA For The Treatment Of Post-Surgical Ocular Pain 8/4/2016
Ampio Pharmaceuticals, Inc. (AMPE) Updates Regulatory Status Of AMPION 8/3/2016
Struggling Telesta (TSX:TST) Cuts Another 30% of Workforce, Will Shutter Montreal Facility 8/2/2016
Amerigen Pharmaceuticals Announces Final Approval From FDA For Generic Version Of Lysteda 8/2/2016
Ipsen (IPN.PA) Announces FDA Approval Of Dysport (Abobotulinumtoxina) For The Treatment Of Lower Limb Spasticity In Pediatric Patients Aged Two And Older 8/1/2016
Sunovion Pharmaceuticals Inc. Submits New Drug Application For SUN-101/Eflow To The FDA For The Treatment Of Patients With Chronic Obstructive Pulmonary Disease (COPD) 8/1/2016
Adaptimmune (ADAP) Receives Access To Priority Medicines (PRIME) Regulatory Support For Its SPEAR T-Cell Therapy Targeting NY-ESO For Treatment Of Soft Tissue Sarcoma 7/28/2016
Newron Pharma (NWRN) To Re-Submit U.S. NDA For Xadago (Safinamide) 7/26/2016
FDA Spurns Ocular Therapeutix (OCUL)'s Post-Operative Eye Pain Treatment 7/25/2016
FDA Rejects Valeant (VRX) Glaucoma Drug, Raises Concerns Over Manufacturing Issues 7/22/2016
Amid Trial Concerns, FDA Delays Approval Decision for Merck & Co. (MRK)'s C. Diff Drug, New PDUFA Date Set 7/22/2016
Puma Biotech (PBYI) Submits New Drug Application For PB272 (Neratinib) To U.S. FDA For Extended Adjuvant Treatment Of HER2-Positive Early Stage Breast Cancer 7/22/2016
Amgen (AMGN) And UCB Submit Biologics License Application For Romosozumab To The FDA 7/22/2016
Ipsen (IPN.PA) And Its Partner Exelixis (EXEL) Receive Positive CHMP Opinion For Cabometyx (Cabozantinib) For The Treatment Of Advanced RCC In Adults Following Prior VEGF-Targeted Therapy 7/22/2016
FDA Panel Says Valeant (VRX)'s Psoriasis Med Should be Approved with Risk Plan 7/20/2016
Lannett (LCI) Announces Receipt Of FDA Acceptable Filing Letter For Fentanyl Patch ANDA 7/20/2016
Lannett (LCI) Announces Receipt Of FDA Acceptable Filing Letter For Fentanyl Patch ANDA 7/20/2016
FDA Spurns Novartis AG (NVS)'s Copy of Amgen (AMGN) Blockbuster Neulasta 7/19/2016
Eisai Inc. (ESALF.PK) And Arena (ARNA) Announce FDA Approval Of BELVIQ XR (Lorcaserin Hcl) Extended-Release Tablets 7/19/2016
FDA Panel Divided on Valeant (VRX)'s Psoriasis Drug Suicide Risk 7/18/2016
Clinuvel To File New Drug With FDA 7/18/2016
Elite Pharma (ELI) Release: FDA Issues Complete Response Letter for SequestOx New Drug Application 7/18/2016
Elite Pharma (ELI) To Host Conference Call To Discuss SequestOx Complete Response Letter On Monday, July 18, 2016 At 8:30 AM EDT 7/18/2016
Synergy Pharma Provides Update On Ongoing FDA Review Of Plecanatide CIC NDA And IBS-C Clinical Development Program 7/15/2016
Fera Pharmaceuticals And Oakwood Laboratories Announce ANDA Approval Of Levothyroxine Sodium For Injection 7/15/2016
FDA Hits DMD Drugmaker Santhera (SANN.SW) With Lengthy Delay 7/14/2016
Amgen (AMGN) Inches Closer to Selling Cheaper Version of AbbVie (ABBV)'s Blockbuster Humira 7/13/2016
Amgen (AMGN) To Discuss Data Supporting Biologics License Application For ABP 501, A Biosimilar Candidate To Adalimumab 7/12/2016
Cipher Pharma (DND.TO) Announces Ozenoxacin Accepted For Review By Health Canada 7/12/2016
FDA Staff Says Novartis AG (NVS) Copy of Amgen (AMGN)'s Blockbuster Enbrel is 'Highly Similar' 7/11/2016
Lannett (LCI) Announces Approval And Launch Of Paroxetine Extended Release Tablets USP, 12.5 Mg, 25 Mg, 37.5 Mg 7/11/2016
Sanders, Other Lawmakers Urge FDA Approval Of Generic Crestor 7/8/2016
FDA Staff Says Amgen (AMGN) Biosimilar is 'Highly Similar' to AbbVie (ABBV)'s Blockbuster Humira 7/8/2016
Teligent Receives Two FDA Approvals For Topical Prescription Portfolio 7/8/2016
TherapeuticsMD (TXMD) Announces New Drug Application Submission For Yuvvexy (TX-004HR) 7/8/2016
Medicure (MCU) Receives Response Letter From FDA On AGGRASTAT sNDA For New Indication 7/8/2016
Cempra (CEMP) Stashes Cash to Focus on Marketing Its New Anti-Bacterial Once FDA Gives It Thumb’s-Up 7/7/2016
IntelliPharmaCeutics Reports Update On Rexista XR: FDA Grants Waiver Of NDA Filing Fee, And Topline Pharmacokinetics Results Indicate No Food Effect 7/5/2016
Takeda (TKPYY) Submits A New Drug Application For Novel, Oral Proteasome Inhibitor Ixazomib In Japan 7/5/2016
DURECT (DRRX)’s PDUFA Date for Remoxy NDA of Sept 25 Unchanged 7/1/2016
GeoVax Labs Inc. (GOVX.OB) Announces Filing Of Investigational New Drug Application For HIV Human Clinical Trial 7/1/2016
Array BioPharma (ARRY) Submits Binimetinib New Drug Application To U.S. FDA 7/1/2016
TherapeuticsMD (TXMD) Announces Filing Timeline For Yuvvexy (TX-004HR) New Drug Application 6/30/2016



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