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Clinical - BLA/NDA/ANDA
Intra-Cellular Therapies (ITCI) Announces Positive Regulatory Update On Schizophrenia Program 8/23/2017
Sarepta (SRPT)’s Exondys 51 Saga Continues as More Details About FDA’s Criticism Uncovered 8/22/2017
Alkermes (ALKS) Initiates Rolling Submission Of ALKS 5461 New Drug Application For Major Depressive Disorder 8/21/2017
The FDA Finds Cardiome (COM.TO)'s Brinavess Data Package Insufficient For NDA Resubmission 8/21/2017
NicOx SA (COX.PA) Announces That Its Exclusive Licensee Submits Response To CRL For Latanoprostene Bunod Ophthalmic Solution, 0.024% 8/18/2017
Vectura (VEC.L) Release: Hikma (HIK.L) Interim Results Statement On Its ANDA For Generic Advair Diskus (VR315) 8/17/2017
This is What Happens When the FDA Approves Cancer Drugs Too Quickly 8/17/2017
Exelixis (EXEL) Submits U.S. Supplemental New Drug Application For CABOMETYX (Cabozantinib) For The Treatment Of Previously Untreated Advanced Kidney Cancer 8/16/2017
Seattle Genetics (SGEN) Release: FDA Accepts Supplemental Biologics License Application And Grants Priority Review For ADCETRIS (Brentuximab Vedotin) In Cutaneous T-Cell Lymphoma 8/16/2017
Portola (PTLA) Announces Andexxa (Andexanet Alfa) Biologics License Application Resubmission Accepted For Review By U.S. FDA 8/15/2017
Evoke Pharma (EVOK) Initiates Comparative Exposure Pharmacokinetic Study For Gimoti 8/14/2017
Lipocine (LPCN) Announces FDA Acknowledgement Of TLANDO (“LPCN 1021”) NDA Resubmission; PDUFA Goal Date, February 8, 2018 8/14/2017
Gilead (GILD)'s HIV Triple Combo Gets Sped-up FDA Review, Decision Date Locked Down 8/11/2017
TherapeuticsMD (TXMD) Provides TX-004HR Regulatory Update 8/11/2017
Lipocine (LPCN) Resubmits NDA For Its Oral Testosterone Product Candidate, LPCN 1021, For Treatment Of Hypogonadism 8/9/2017
Valeant (VRX) Receives Complete Response Letter From The FDA For Latanoprostene Bunod Ophthalmic Solution, 0.024% NDA 8/8/2017
FDA Approves Medicines360's sNDA For LILETTA (Levonorgestrel-Releasing Intrauterine System) 52 Mg To Prevent Pregnancy For Up To Four Years 8/7/2017
Genentech (RHHBY) Release: FDA Grants Priority Review And Breakthrough Therapy Designation For Zelboraf (Vemurafenib) In Erdheim-Chester Disease With BRAF V600 Mutation 8/7/2017
Vernalis (VNLPY.PK) Hit by U.S. Setback for Cough and Cold Drug CCP-08 8/7/2017
Mylan (MYL) Receives Tentative Approval for "TLD" Under PEPFAR 8/7/2017
FDA Advisory Panel Votes Against Approval Of Johnson & Johnson (JNJ)’s Sirukumab 8/4/2017
Pfizer (PFE) Release: FDA Advisory Committee Votes In Favor Of XELJANZ (Tofacitinib Citrate) For The Treatment Of Active Psoriatic Arthritis 8/4/2017
Portola (PTLA) Announces Resubmission Of Biologics License Application For AndexXa (Andexanet Alfa) 8/4/2017
FDA Grants Genentech (RHHBY)’s Alecensa Priority Review For Initial Treatment Of People With ALK-Positive Lung Cancer 8/3/2017
8 PDUFA Dates to Watch in August 8/2/2017
Realm Therapeutics: Submission Of Investigational New Drug Application 8/2/2017
Kitov (KTOV) Submits New Drug Application To FDA For KIT-302 8/1/2017
Amgen (AMGN) And Allergan (AGN) Submit Biosimilar Biologics License Application For ABP 980 To FDA 7/31/2017
Amgen (AMGN) Submits Supplemental Biologics License Application For Prolia (denosumab) In Glucocorticoid-Induced Osteoporosis 7/31/2017
Indivior Announces FDA Acceptance With Priority Review Designation Of RBP-6000 Buprenorphine Monthly Depot New Drug Application (NDA) For The Treatment Of Opioid Use Disorder 7/31/2017
Recro Pharma (REPH) Submits New Drug Application For IV Meloxicam 30mg 7/31/2017
Celltrion And Teva (TEVA) Announce U.S. FDA Acceptance Of Biologics License Application For Proposed Biosimilar To Herceptin(Trastuzumab) 7/31/2017
Agile Therapeutics, Inc. Announces FDA Acceptance Of The NDA Resubmission Of Twirla 7/28/2017
FDA Grants Priority Review For Amgen (AMGN)'s Supplemental Biologics License Application For Repatha (evolocumab) To Include Data On Reducing Risk Of Cardiovascular Events 7/28/2017
Advanced Accelerator Applications Completes Resubmission Of NDA For Lutetium Lu 177 Dotatate (Lutathera) To FDA 7/27/2017
Capricor (CAPR) Announces Results Of FDA Meeting On Intravenous CAP-1002 For Duchenne Muscular Dystrophy 7/27/2017
U.S. FDA Grants Priority Review For An Epinephrine Auto-Injector In Development By Kaleo Specifically For Infants And Small Children 7/27/2017
Aradigm (ARDM) Submits New Drug Application (NDA) To FDA For U.S. Marketing Approval Of Linhaliq In Non-Cystic Fibrosis Bronchiectasis 7/27/2017
Intellipharmaceutics (IPCI) Provides Update On FDA Advisory Committees Meeting For Rexista (Oxycodone Hydrochloride Extended Release), An Abuse-Deterrent Opioid Analgesic For The Treatment Of Moderate To Severe Pain 7/27/2017
Merck & Co. (MRK) Plans to File NDA for HIV Treatment Doravirine Based on Phase III Results 7/26/2017
Ablynx (ABLYF) Receives Fast Track Designation From The FDA For Caplacizumab For The Treatment Of Acquired TTP 7/26/2017
Blood Clot Fears Delay Eli Lilly (LLY), Incyte (INCY)'s Potential Rheumatoid Arthritis Blockbuster, Stocks Fall 7/25/2017
Massachusetts’ Histogenics Looks to NeoCart for Replacing Knee Cartilage Loss 7/25/2017
Eisai Inc. (ESALF.PK) Submits Supplemental New Drug Application To FDA For Lenvatinib In First-Line Hepatocellular Carcinoma 7/25/2017
HedgePath Pharmaceuticals Receives Clarity From FDA Regarding Pathway To Potential Regulatory Submission 7/25/2017
FDA Accepts Bristol-Myers Squibb (BMY)’s Applications For Opdivo (Nivolumab) Four-Week Dosing Schedule Across All Approved Indications 7/25/2017
UCB SA And Dermira (DERM) Announce U.S. And EU Regulatory Submissions For CIMZIA (Certolizumab Pegol) For The Treatment Of Moderate-To-Severe Chronic Plaque Psoriasis 7/25/2017
Amgen (AMGN) Release: FDA Accepts Biologics License Application For Aimovig (erenumab) 7/21/2017
FDA Accepts Biologics License Application For AMG 334 (Erenumab), An Important Regulatory Milestone For Novartis AG (NVS) 7/21/2017
New Braeburn Pharma CEO Has Company on Track with Filing for Opioid Addiction Drug NDA 7/21/2017
Braeburn Pharma And Camurus Announce Submission Of NDA For Long-Acting Buprenorphine (CAM2038) For Opioid Use Disorder 7/20/2017
Churchill Pharmaceuticals Announces NDA Filing Acceptance For YONSA By The U.S. FDA 7/20/2017
Merck & Co. (MRK) Announces U.S. FDA Grants Tentative Approval For LUSDUNA™ Nexvue™ (Insulin Glargine Injection), A Follow-On Biologic Basal Insulin 7/20/2017
Teva (TEVA) Release: NICE Recommends CINQAERO (Reslizumab) For The Treatment Of Severe Eosinophilic Asthma 7/20/2017
Trevena (TRVN) To Host 2017 Analyst Day And Announce Results Of ATHENA Open Label Safety Study Of OLINVO 7/20/2017
Spark Therapeutics (ONCE) Receives Rare Pediatric Disease Designation For Investigational LUXTURNA (Voretigene Neparvovec) From FDA 7/20/2017
AEterna Zentaris (AEZS) Release: NDA For Macrilen For The Evaluation Of Growth Hormone Deficiency In Adults Granted December 30, 2017 PDUFA Date 7/19/2017
FDA Accepts CSL Behring's Supplemental Biologics License Application For Hizentra Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Indication 7/19/2017
Evolus Announces FDA Acceptance For Review Of The Biologics License Application For DWP-450 Neuromodulator 7/19/2017
Safety Issues Force the FDA to Turn Down Amgen (AMGN), UCB SA's Osteoporosis Drug 7/18/2017
Otonomy (OTIC) Announces FDA Acceptance Of OTIPRIO Supplemental New Drug Application Filing For Acute Otitis Externa 7/18/2017
TherapeuticsMD (TXMD) Provides TX-004HR Regulatory Update 7/17/2017
Spark Therapeutics (ONCE)’ Biologics License Application For Investigational Voretigene Neparvovec Accepted For Filing By FDA 7/17/2017
FDA Oncologic Drugs Advisory Committee Unanimously Recommends Approval Of Mylan (MYL) And BioCon (BIOCON.NS)'s Proposed Biosimilar Trastuzumab 7/14/2017
Amgen (AMGN) Submits Regulatory Applications In U.S. And Europe To Include Overall Survival Data In Kyprolis (Carfilzomib) Label 7/14/2017
FDA Panel Unanimously Endorses Novartis AG (NVS)'s CAR-T Leukemia Drug 7/14/2017
Amgen (AMGN) And Allergan (AGN) To Discuss Data Supporting Biologics License Application For ABP 215, A Biosimilar Candidate To Avastin (Bevacizumab) 7/13/2017
Pfizer (PFE) Announces FDA Accepts Supplemental New Drug Application For XELJANZ (Tofacitinib Citrate) For The Treatment Of Adult Patients With Moderately To Severely Active Ulcerative Colitis 7/13/2017
The Alliance For Regenerative Medicine Issues Statement On U.S. FDA Oncologic Drugs Advisory Committee Meeting Regarding FDA CAR-T Product Biologics License Application 7/13/2017
FDA Spurns Ocular Therapeutix (OCUL)'s Eye Drug Again Despite Eleventh Hour Scramble 7/12/2017
FDA Advisory Committee Votes In Favor Of Pfizer (PFE)’s MYLOTARG (Gemtuzumab Ozogamicin) For Acute Myeloid Leukemia 7/12/2017
Waiting Lists are Already Forming for Novartis AG (NVS) and Kite Pharma (KITE)'s Not-Yet Approved CAR-T Drugs 7/11/2017
The FDA Has Accepted An Orphan Designation Request For Use Of Truveta Administered Intranasally Submitted By Axium Pharmaceuticals 7/11/2017
Oncoceutics Extends Patent Family To Include ONC201 In Leukemias 7/11/2017
Novartis AG (NVS) Avoided Deaths In CAR-T Trials But Long-Term Safety Is Key, Says The FDA 7/11/2017
Groundbreaking: Amicus (FOLD) Surges as the FDA Changes Its Tune on Fabry Disease Drug 7/11/2017
FDA Grants Priority Review For Eli Lilly (LLY)'s Abemaciclib For The Treatment Of Advanced Breast Cancer 7/10/2017
Actinium (ATNM.OB) To Host Webinar Focused On Actimab-A And Recent Developments Related To CD33 Targeted AML Therapies On July 13, 2017 At 8:00 Am ET 7/6/2017
5 Biotechs Awaiting Big News From the FDA in July 7/6/2017
Array BioPharma (ARRY) Submits New Drug Applications To FDAFor Binimetinib And Encorafenib In Advanced Melanoma 7/5/2017
Cardiome Pharma Corp. (COM.TO)'s Partner SteadyMed (STDY) Submits U.S. New Drug Application For TREVYENT For The Treatment Of Pulmonary Arterial Hypertension 7/5/2017
PROMETHERA Biosciences S.A./N.V. Announces Review Acceptance Of Heparesc New Drug Submission For Neonatal Onset Urea Cycle Disorders By Health Canada 7/5/2017
Acorda (ACOR) Submits New Drug Application To U.S. FDA For INBRIJATM (CVT-301, Levodopa Inhalation Powder) 6/30/2017
AEterna Zentaris (AEZS) Resubmits NDA For Macrilen For The Evaluation Of Growth Hormone Deficiency In Adults 6/30/2017
Sunovion Announces FDA Acceptance For Review Of Supplemental New Drug Application For Latuda (Lurasidone HCI) For The Treatment Of Bipolar Depression In Children And Adolescents 6/30/2017
Sunovion Announces FDA Acceptance For Review Of New Drug Application Resubmission For SUN-101/Eflow (Glycopyrrolate) For The Treatment Of Chronic Obstructive Pulmonary Disease (COPD) 6/30/2017
BioMarin (BMRN) Submits Pegvaliase Biologics License Application (BLA) To The U.S. FDA For Treatment Of Phenylketonuria (PKU) 6/30/2017
Astellas (ALPMY) Submits Supplemental New Drug Application For Mirabegron For Use In Combination With Solifenacin Succinate 5 Mg For The Treatment Of Overactive Bladder 6/30/2017
FDA Unveils Plan To Eliminate Orphan Designation Backlog 6/30/2017
Salix (SLXP) Announces Filing Acceptance For PLENVU Next Generation Bowel Cleansing Preparation For Colonoscopies 6/29/2017
Celltrion And Teva (TEVA) Announce U.S. FDA Acceptance Of Biologics License Application For Proposed Biosimilar To Rituxan (Rituximab) 6/29/2017
Janssen R&D Release: U.S. FDA Grants Priority Review Of XARELTO (Rivaroxaban) sNDA For A 10 Mg Dose To Reduce The Risk Of Recurrent Venous Thromboembolism (VTE) 6/28/2017
Global Blood Therapeutics (GBT) Receives EMA PRIME Designation For GBT440 For The Treatment Of Sickle Cell Disease (SCD) 6/28/2017
Amicus (FOLD) Submits Japanese New Drug Application For Migalastat For Fabry Disease 6/28/2017
Kitov (KTOV) Updates On KIT-302 New Drug Application 6/27/2017
Agile Therapeutics, Inc. Resubmits New Drug Application (NDA) For Its Transdermal Contraceptive Patch, Twirla 6/27/2017
AMAG (AMAG) Announces U.S. FDA Filing Acceptance Of Supplemental New Drug Application For Makena® (Hydroxyprogesterone Caproate Injection) Subcutaneous Auto-Injector 6/26/2017
Zosano (ZSAN) Announces Outcome Of End Of Phase II Meetings With FDA 6/26/2017
ICON Annouces FDA Acceptance Of NDA Filing For DEXYCU, A Noval Drug Therapy For Treating Inflammation Associated With Cataract Surgery 6/26/2017
Clarus Therapeutics Re-Submits JATENZO NDA Following Positive Results Of inTUne Trial 6/26/2017
Novo Nordisk A/S (NVO): CHMP Adopts Positive Opinion For EU Label Update Of Victoza Based On The LEADER Trial 6/23/2017
Plant Problems Lead The FDA To Reject Pfizer (PFE)'s Epogen Biosimilar Again 6/23/2017
H. Lundbeck A/S (LUN.CO) And Takeda (TKPYY) Receive Complete Response Letter From The FDA For Trintellix (Vortioxetine) Snda 6/23/2017
Novo Nordisk A/S (NVO) Receives Positive 17-2 Vote From FDA Advisory Committee That Victoza Provides Substantial Evidence Of Cardiovascular Risk Reduction In Patients With Type 2 Diabetes 6/21/2017
Novartis AG (NVS) Achieves Important Regulatory Milestone For AMG 334 (Erenumab) In Migraine Prevention With EMA Filing Acceptance 6/21/2017
Seattle Genetics (SGEN) Submits Supplemental Biologics License Application To FDA For ADCETRIS (Brentuximab Vedotin) In Cutaneous T-Cell Lymphoma 6/20/2017
FDA Accepts Sandoz Regulatory Submission For A Generic Version Of Advair Diskus 6/19/2017
FDA Accepts Rigel (RIGL)'s New Drug Application For TAVALISSE (Fostamatinib Disodium) For The Treatment Of Chronic ITP 6/19/2017
FDA Accepts Amgen (AMGN)'s Supplemental Biologics License Application To Expand Indication For XGEVA (Denosumab) To Include Multiple Myeloma Patients 6/19/2017
ResQ Pharma Receives FDA Orphan Drug Designation For Lipidrescue Therapy For The Treatment Of Local Anesthetic Systemic Toxicity 6/16/2017
Achelios Therapeutics Concludes Successful Type C Meeting With FDA Regarding Its Lead Product, TOPOFEN, For Prevention And Treatment Of Migraine 6/14/2017
Braeburn Pharma And Knight Therapeutics Announce Filing Of New Drug Submission For PROBUPHINE In Canada For Opioid Drug Dependence 6/13/2017
Bay Area's Coherus Craters After the FDA Spurns Its Biosimilar for Amgen (AMGN)'s Neulasta 6/13/2017
Hutchison China MediTech (Chi-Med) Submits New Drug Application To CFDA For Fruquintinib In Advanced Colorectal Cancer 6/12/2017
Bioverativ (BIVV) Announces FDA Acceptance Of Investigational New Drug Application For BIVV001 To Treat Hemophilia A 6/12/2017
Gilead (GILD) Submits New Drug Application To U.S. FDA For Fixed-Dose Combination Of Bictegravir, Emtricitabine And Tenofovir Alafenamide For HIV Treatment 6/12/2017
Booming Glenmark Pharma Could File One NDA Each Year For 10 Years 6/9/2017
CytRx (CYTR) Announces Update On The Regulatory Pathway For Aldoxorubicin In Soft Tissue Sarcomas 6/8/2017
Mark Your Calendars: Novartis AG (NVS)'s CAR-T Drug Gets A Date With The FDA Next Month 6/7/2017
PTC Therapeutics (PTCT) Announces FDA Advisory Committee Meeting For Ataluren For The Treatment Of Nonsense Mutation Dystrophinopathy 6/6/2017
Synergy Pharma (SGYP) Announces Acceptance Of Supplemental New Drug Application (sNDA) For TRULANCE (Plecanatide) For The Treatment Of Adults With Irritable Bowel Syndrome With Constipation (IBS-C) 6/6/2017
Amgen (AMGN) Submits Regulatory Applications For Repatha (evolocumab) Cardiovascular Outcomes Data In U.S. And Europe 6/5/2017
Noden Pharma Notified Of ANDA Filing For Tekturna 6/5/2017
Biocryst (BCRX) Announces RAPIVAB Pediatric sNDA Acceptance 6/5/2017
10 Biotechs Awaiting FDA Decisions in June 6/2/2017
GlaxoSmithKline (GSK) Quietly Paid $130 Million for HIV Priority Voucher to Beat Gilead (GILD) to the Finish Line 6/2/2017
Jazz Pharma (JAZZ) Announces FDA Acceptance Of NDA For VYXEOS (CPX-351), An Investigational Treatment For Acute Myeloid Leukemia, With Priority Review Status 6/1/2017
Protalix Biotherapeutics, Inc. (PLX) Announces FDA Approval To Operate Its Current Facility As A Multi-Product Facility 6/1/2017
Evoke Pharma (EVOK) Enters Agreement With Rho To Submit NDA For Gimoti 5/31/2017
Sandoz Proposed Biosimilars Adalimumab And Infliximab Accepted For Regulatory Review By The EMA 5/31/2017
TiGenix Provides Regulatory Update On Cx601 EU Marketing Authorization Application Procedure 5/31/2017
TaiGen Biotechnology Submits NDA In China For Novel IV Antibiotic 5/31/2017
Why June Could be a Pivotal Month for These 2 Biotechs 5/31/2017
KaloBios (KBIO) Submits IND Application For Benznidazole To FDA 5/30/2017
Novo Nordisk A/S (NVO) Submits Application In The US For Including Data From The DEVOTE Trial In The Tresiba Label 5/30/2017
TaiGen Biotechnology Announces Submission Of New Drug Application For Taigexyn Intravenous Formulation To The China Food And Drug Administration 5/30/2017
FDA Rejects Sunovion's COPD NDA For SUN-101/eFlow 5/30/2017
Kite Pharma (KITE) Catches Up With Novartis AG (NVS) As CAR-T BLA Gets Priority Review Status 5/30/2017
Rigel (RIGL): Tavalisse NDA Will Be A Game-Changer 5/26/2017
Kite Pharma (KITE) Receives FDA Priority Review For Axicabtagene Ciloleucel 5/26/2017
Puma Biotech (PBYI) Defies Odds, Wins FDA Backing for Breast Cancer Drug 5/25/2017
There’s A Therapeutic Curveball Heading For The FDA 5/25/2017
Sun Pharma (SUNPHARMA.NS) Announces U.S. FDA Filing Acceptance Of Biologics License Application (BLA) For Tildrakizumab 5/24/2017
FDA Accepts For Priority Review Bristol-Myers Squibb (BMY)’s Application For Opdivo (Nivolumab) In Previously Treated Hepatocellular Carcinoma 5/24/2017
Churchill Pharmaceuticals Announces Submission Of NDA For Novel Oral Formulation Of Prostate Cancer Treatment 5/23/2017
Puma Biotech (PBYI) Surges on the FDA's Positive Breast Cancer Review 5/23/2017
FDA Grants Priority Review To Merck & Co. (MRK)’s Supplemental Biologics License Application (sBLA) For KEYTRUDA (Pembrolizumab) For Treatment Of Recurrent Or Advanced Gastric Or Gastroesophageal Junction Adenocarcinoma 5/23/2017
Otsuka Pharma And Proteus Digital Health Resubmit Application To FDA For First Digital Medicine 5/23/2017
Ultragenyx (RARE) Announces Recombinant Human Beta-Glucuronidase Biologics License Application And Marketing Authorization Application Filed And Accepted For Review; FDA Grants Priority Review Status 5/23/2017
Intersect ENT Announces PDUFA Date For Office-Based SINUVA Steroid Releasing Sinus Implant 5/22/2017
Sunovion Release: U.S. FDA Accepts For Review Supplemental New Drug Application For Aptiom (Eslicarbazepine Acetate) For The Treatment Of Partial-Onset Seizures In Children 4 To 17 Years Of Age 5/22/2017
Amgen (AMGN) Submits Biologics License Application To The FDA For Erenumab 5/19/2017
AVEO Oncology (AVEO) Announces Completion Of A CHMP Oral Explanation For Tivozanib As A Treatment Of First-Line Renal Cell Carcinoma 5/19/2017
Novartis AG (NVS) Receives Positive CHMP Opinion For First-Line Use Of Zykadia In ALK-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) 5/19/2017
Vifor Pharma Release: CHMP Recommends Veltassa For The Treatment Of Hyperkalaemia In The EU 5/19/2017
Sanofi (SNY) Receives CHMP Recommendation For Approval Of Insulin Lispro Biosimilar 5/19/2017
Merck & Co. (MRK) Receives CHMP Positive Opinion Recommending Approval Of ISENTRESS (Raltegravir) 600 mg In The European Union 5/19/2017
XBiotech (XBIT) Sinks To A New Low After The EMA Rejects Lead Drug 5/19/2017
Confident Johnson & Johnson (JNJ) Flexes Its Muscles, Plans 10 Blockbuster Approvals by 2021 5/18/2017
Abon Pharmaceuticals Received Approval from the U.S. FDA for Clofarabine Injection 5/17/2017
Can-Fite BioPharma (CFBI) Files Clinical Trial Application In Canada For Piclidenoson Ahead Of Upcoming Acrobat Rheumatoid Arthritis Phase III Study 5/16/2017
Alphaeon Submits Biologics License Application For DWP-450 Neuromodulator 5/16/2017
Aerie (AERI) Announces FDA Acceptance Of NDA Submission For Rhopressa (Netarsudil Ophthalmic Solution) 0.02% 5/15/2017
Avita Medical Release: Initial Pre-Emergency Use Authorization Submission Made To U.S. FDA For Use Of ReCell In A Mass Casualty Scenario 5/10/2017
Savara Announces Expedited U.S. Molgradex Development Strategy 5/10/2017
FDA Accepts Aclaris (ACRS)’ New Drug Application For Topical Treatment Of Seborrheic Keratosis, A Common Skin Condition 5/10/2017
Nymox (NYMX) Files For Approval Of First In Class Prostate Drug In Europe: Teleconference At 4:30 EDT 5/10/2017
Investigational New Drug Application Is Now Effective For Babesia Screening In Blood Donations Using Grifols (GRFS) Procleix Panther System In The U.S. 5/9/2017
Fast-Growing Intarcia Awaits Crucial FDA Decision in New Boston HQ 5/8/2017
Conspiracy Theory: Did Puma Biotech (PBYI) Exec Resign Because of Bad News Ahead? 5/8/2017
Turmoil Hits As TherapeuticsMD (TXMD)'s Vaginal Pain Drug Gets Rejected By The FDA 5/8/2017
Nymox (NYMX) Files For Approval Of First In Class Prostate Drug In Europe: Company To Hold Teleconference Wednesday May 10 At 4:30 EDT 5/8/2017
4 Biotechs That Could Explode Or Crash In May 5/5/2017
Theratechnologies (TH.TO) Partner Submits Biologics License Application For HIV Monoclonal Antibody And Long-Acting Investigational Antiretroviral Ibalizumab 5/4/2017
Pfizer (PFE) Announces U.S. FDA Filing Acceptance Of Supplemental New Drug Application For XELJANZ (Tofacitinib Citrate) For The Treatment Of Adult Patients With Active Psoriatic Arthritis 5/3/2017
Janssen R&D Submits Supplemental New Drug Application To U.S. FDA Based On EINSTEIN CHOICE Data, Which Showed Superiority With XARELTO (Rivaroxaban) Versus Aspirin In Reducing Risk Of Recurrent Venous Thromboembolism (VTE), With Low Rates Of Major Bleeding Across Groups 5/1/2017
Atlantic Healthcare Initiates FDA Rolling Submission Of Its New Drug Application For Alicaforsen In The Treatment Of Pouchitis 5/1/2017
Mark Your Calendars: 4 Biotechs Facing FDA Decision Dates in May 4/28/2017
Ignyta (RXDX) Updates Progress Towards Entrectinib Dual TRK And ROS1 NDA Submissions 4/28/2017
Sanofi (SNY) And Regeneron (REGN) Announce Kevzara (Sarilumab) Biologics License Application Resubmission Accepted For Review By The FDA 4/28/2017
Tesaro (TSRO) Initiates Registrational Development Program For Anti-PD-1 Antibody TSR-042 4/27/2017
Why High-Flying M&A Target Tesaro (TSRO) Recently Lost More Than a Quarter of Its Value 4/26/2017
Aratana Therapeutics (PETX) Provides Update On ENTYCE 4/26/2017
CPhI Expert Calls For ANDA Approvals To Be Reduced By Two-Thirds In Order To Lower Drug Costs 4/26/2017
Eli Lilly (LLY) Gives No New Information On Rheumatoid Arthritis Drug Delay 4/26/2017
Orexigen (OREX) Announces New Drug Submission For Contrave In Canada 4/25/2017
uniQure (QURE) Receives EMA Priority Medicines (PRIME) Designation For AMT-060 In Hemophilia B 4/25/2017
Immune Therapeutics Files Lodonal New Drug Application In Kenya 4/25/2017
Santen Announces U.S. FDA Filing Acceptance Of New Drug Application (NDA) For Intravitreal Sirolimus (DE-109) In The Treatment Of Non-Infectious Uveitis Of The Posterior Segment 4/25/2017
Vernalis PLC (VNLPY.PK): FDA Issues A Complete Response Letter On CCP-07 NDA 4/24/2017
Sandoz Proposed Biosimilars Rituximab And Etanercept Recommended For Approval In Europe* 4/24/2017
Sanofi (SNY) And Regeneron (REGN) Receive CHMP Positive Opinion For Kevzara (Sarilumab) To Treat Adult Patients With Moderately To Severely Active Rheumatoid Arthritis 4/24/2017
XBiotech (XBIT) Craters After Disappointing EMA Meeting 4/21/2017
Vernalis PLC (VNLPY.PK) Tanks After the FDA Spurns Cough-Cold Drug Filing 4/21/2017
FDA's Shorten Review Time is a Bad Sign for Puma Biotech (PBYI)'s Controversial Cancer Drug 4/20/2017
TherapeuticsMD (TXMD) Provides Additional Information On TX-004HR Regulatory Update 4/19/2017
Sunovion To Present Data On Aptiom (Eslicarbazepine Acetate) At American Academy of Neurology 2017 Annual Meeting 4/19/2017
Egalet Announces FDA Acceptance Of File For Prior Approval Supplement For OXAYDO (Oxycodone Hcl, USP) Tablets C-II 10 Mg And 15 Mg Dosage Strengths 4/18/2017
Rigel (RIGL) Submits New Drug Application To FDA For Fostamatinib In Chronic ITP 4/18/2017
Emmaus Life Sciences Announces FDA Advisory Committee Meeting For Endari For Sickle Cell Disease 4/18/2017



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