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Clinical - BLA/NDA/ANDA
Bristol-Myers Squibb (BMY) Receives Positive CHMP Opinion Recommending Opdivo (Nivolumab) For The Treatment Of Squamous Cell Cancer Of The Head And Neck In Adults Progressing On Or After Platinum-Based Therapy 3/24/2017
Symbiomix Announces FDA's Acceptance Of New Drug Application For Solosec With Priority Review Status 3/23/2017
Advaxis (ADXS) Release: EMA Certification Paves The Way For The MAA Submission For Axalimogene Filolisbac In Metastatic Cervical Cancer 3/23/2017
Sunesis (SNSS) Announces Submission Of Responses To The EMA Day 180 List Of Outstanding Issues For Marketing Authorization Application For Vosaroxin 3/22/2017
Esperion (ESPR) Hits A New High After Positive Feedback For Its Heart Drug From The FDA 3/21/2017
Mylan (MYL) Receives Tentative Approval For "TLE400" Under PEPFAR 3/21/2017
Pain Therapeutics (PTIE) Announces Positive Regulatory Guidance For REMOXY ER 3/21/2017
Why This Biotech Says It's Close to Curing the Type of Cancer That Killed Steve Jobs 3/20/2017
Array BioPharma (ARRY) Withdraws Skin Cancer NDA for Binimetinib 3/20/2017
FDA Deals Another Blow to AstraZeneca PLC (AZN)'s Blood Drug 3/20/2017
Alkermes (ALKS) To Present Data On Two-Month Dosing Option Of ARISTADA At 16th International Congress On Schizophrenia Research 3/20/2017
Agile Therapeutics, Inc. Announces A Poster Presentation Of Its SECURE Phase III Study At The Contraceptive Technology 2017 Conference 3/17/2017
Immune Therapeutics Clears Critical Regulatory Hurdle For Lodonal In Kenya 3/17/2017
Merck & Co. (MRK) Provides Update On Supplemental Biologics License Application (sBLA) For KEYTRUDA (Pembrolizumab) In Previously Treated Advanced Microsatellite Instability-High Cancer 3/15/2017
GlaxoSmithKline (GSK) Announces US Regulatory Submission Seeking Expanded Indication For Fluarix Quadrivalent (Influenza Vaccine) For Infants 6 Months And Older 3/15/2017
Enanta Pharmaceuticals, Inc. Announces Japanese Ministry Of Health, Labour And Welfare Grants Priority Review For AbbVie (ABBV)’s Investigational HCV Regimen Of Glecaprevir/Pibrentasvir (G/P) For The Treatment Of All Major Genotypes Of Chronic Hepatitis C 3/14/2017
Sunovion Submits Supplemental New Drug Application To FDA For Use Of APTIOM (Eslicarbazepine Acetate) For The Treatment Of Partial-Onset Seizures In Children 4 Years Of Age And Older 3/13/2017
9 Questionable Drugs Biotechs Are Submitting to the FDA in a Hail Mary Pass 3/10/2017
Statement From Health Canada On The Publication Of A White Paper On Public Release Of Clinical Information In Drug Submissions And Medical Device Applications 3/10/2017
Radius Health (RDUS) Falls on PDUFA Extension for Abaloparatide-SC 3/10/2017
NicOx SA (COX.PA) Resubmits AC-170 (ZERVIATE) NDA To The FDA 3/9/2017
Keryx (KERX) Announces U.S. FDA Filing Acceptance Of Supplemental New Drug Application For Auryxia (Ferric Citrate) Tablets 3/8/2017
Allergan (AGN) Release: FDA Accepts Supplemental New Drug Application (sNDA) For VRAYLAR (cariprazine) 3/8/2017
Alexion (ALXN) Release: FDA Accepts sBLA Filing Of Soliris (Eculizumab) As A Potential Treatment For Patients With Refractory Generalized Myasthenia Gravis (gMG) 3/8/2017
Intersect ENT Submits New Drug Application To FDA For Office-Based RESOLVE Steroid Releasing Implant For Recurrent Chronic Sinus Disease 3/8/2017
Merck & Co. (MRK), Pfizer (PFE)'s 4-Year Diabetes Alliance Pays Off With FDA, EMA Filings 3/7/2017
PTC Therapeutics (PTCT) Announces FDA Acknowledgment Of New Drug Application Filing For Translarna For The Treatment Of Nonsense Mutation Duchenne Muscular Dystrophy 3/6/2017
10 Biotechs With an Orphan Drug in Late-Stage Pipeline 3/3/2017
3 Top Biotechs Facing Make-or-Break FDA Decisions This Year 3/3/2017
SCYNEXIS, Inc. (SCYX) Delays Initiation Of New Clinical Studies Using The IV Formulation Of SCY-078 At FDA’s Request 3/3/2017
9 Massachusetts Biotechs Facing Major FDA Decisions This Year 3/3/2017
6 Biotechs Facing Key FDA Decisions in March 3/2/2017
Celgene (CELG) Release: FDA Accepts New Drug Application And Grants Priority Review For Enasidenib In Relapsed Or Refractory AML With An IDH2 Mutation 3/1/2017
Acerus (TRLPF) Files A New Drug Submission For GYNOFLOR In Canada 3/1/2017
Dynavax (DVAX) Announces FDA Acceptance For Review Of Its Complete Response To November 2016 CRL And PDUFA Action Date For HEPLISAV-B 3/1/2017
Aerie (AERI) Announces Resubmission Of NDA For Rhopressa (Netarsudil Ophthalmic Solution) 0.02% 3/1/2017
Melinta Announces FDA Acceptance of Investigational New Drug Application for Topical Radezolid 2/28/2017
Titan Pharma (TTNP) Receives FDA Communication On Ropinirole Implant Investigational New Drug Application 2/28/2017
Pfizer (PFE) Release: FDA Accepts The Biologics License Application For Avelumab For The Treatment Of Metastatic Urothelial Carcinoma For Priority Review 2/28/2017
Teva (TEVA) Announces Priority Review Granted By FDA For SD-809 For Treatment Of Tardive Dyskinesia 2/28/2017
Eagle Pharma (EGRX)’ Pemetrexed NDA Accepted For Filing By The FDA 2/28/2017
Bausch & Lomb And NicOx SA (COX.PA) Resubmit US New Drug Application For Novel Glaucoma Candidate Latanoprostene Bunod 2/27/2017
Aclaris (ACRS) Submits New Drug Application For A-101 As A Novel Treatment For Seborrheic Keratosis – A Common Skin Condition 2/27/2017
Ocular Therapeutix (OCUL) Announces FDA Acceptance Of NDA Resubmission For DEXTENZA For The Treatment Of Ocular Pain Occurring After Ophthalmic Surgery 2/22/2017
Lannett (LCI) Provides Further Update On Methylphenidate ER Tablets 2/22/2017
Alimera Sciences (ALIM) And Knight Therapeutics Announce Filing Of New Drug Submission For Iluvien In Canada 2/22/2017
The Medicines Company (MDCO) Announces FDA Filing Acceptance Of New Drug Application For Intravenous Antibiotic Carbavance (Meropenem-Vaborbactam) 2/21/2017
Pfizer (PFE) Announces Acceptance Of Regulatory Submission For Inotuzumab Ozogamicin By FDA 2/21/2017
FDA Denies Amphastar (AMPH)'s Nasal Opioid Overdose Treatment 2/21/2017
U.S. FDA Accepts Biologics License Application (BLA) For Mylan (MYL) And BioCon (BIOCON.NS)'s Proposed Biosimilar Pegfilgrastim For Review 2/16/2017
Amgen (AMGN) Submits Supplemental Biologics License Application For BLINCYTO (Blinatumomab) In Relapsed Or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia 2/14/2017
FDA Accepts CSL Behring's Biologics License Application Supplement For Using Privigen To Treat Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), A Rare Neurological Condition 2/14/2017
Allergan (AGN) R&D Chief Reveals 6 Drugs That Could be Potential Blockbusters 2/14/2017
FDA Informs Portola (PTLA) At Mid-Cycle Review For Betrixaban That It Has Not Identified Issues That Require An Advisory Committee Meeting 2/8/2017
Flexion (FLXN) Announces New Drug Application For Zilretta (FX006) Accepted By U.S. FDA 2/7/2017
Intarcia Announces FDA Filing Acceptance Of New Drug Application (NDA) For ITCA 650 For The Treatment Of Type 2 Diabetes 2/6/2017
Kindred Bio (KIN) Receives Early Approval Of Effectiveness Technical Section From FDA For Mirataz New Animal Drug Application 2/6/2017
IntelliPharmaCeutics Announces FDA Acceptance For Filing Of NDA For Rexista (Oxycodone Hydrochloride Extended Release), An Abuse Deterrent Opioid Analgesic For The Treatment Of Moderate To Severe Pain 2/3/2017
FDA Accepts Two sBLAs For Merck & Co. (MRK)s KEYTRUDA (Pembrolizumab) For Locally Advanced Or Metastatic Urothelial Cancer In Cisplatin-Ineligible First-Line And Second-Line Post-Platinum Failure Treatment Settings 2/3/2017
Charleston Laboratories And Daiichi Sankyo Receive Complete Response Letter From FDA For New Drug Application For CL-108 (Hydrocodone, Acetaminophen, Promethazine) Tablets For Oral Use 2/3/2017
Enanta Pharmaceuticals, Inc. Announces U.S. FDA Grants Priority Review To AbbVie (ABBV)’s Investigational HCV Regimen Of Glecaprevir/Pibrentasvir (G/P) For The Treatment Of Chronic Hepatitis C In All Major Genotypes (GT1-6) 2/2/2017
Nuvectra (NVTR) Files Regulatory Submissions For FDA And CE Mark Approvals Of The Virtis Sacral Nerve Stimulation (SNS) System 2/2/2017
Albireo (ALBO) Announces Submission Of New Drug Application For Elobixibat In Japan 2/1/2017
6 Biopharma Companies Face Catalysts in February 1/31/2017
OptiNose AS Announces FDA Acceptance For Filing Of The New Drug Application For OPN-375 1/31/2017
FDA Approves Allergan (AGN)'s sNDA For AVYCAZ (Ceftazidime And Avibactam) To Include New Phase III Data In Patients With Complicated Urinary Tract Infections (cUTI), Including Pyelonephritis 1/30/2017
Relmada Therapeutics Release: Pharma To Provide An Update On The Development Plan For LevoCap ER 1/25/2017
Atlantic Healthcare Release: Pharma Receives FDA Agreement To Initiate Rolling Submission Of Its New Drug Application For Alicaforsen In The Treatment Of Pouchitis 1/24/2017
Elite Pharma (ELI) Release: Company Reports On SequestOx FDA End-of-Review Meeting 1/23/2017
Ocular Therapeutix (OCUL) Release: Biopharma Resubmits NDA For DEXTENZA For The Treatment Of Ocular Pain Occurring After Ophthalmic Surgery 1/23/2017
Eagle Pharma (EGRX) Release: Company Completes NDA Submission For Ryanodex For Exertional Heat Stroke To FDA 1/23/2017
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
Streamlined Development Process For Certain New Drug Applications Is Not Facilitating Shorter Approval Times, According To Tufts Center for the Study of Drug Development 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
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
Ironwood (IRWD) Announces New Drug Application For DUZALLO (Fixed-Dose Combination Of Lesinurad And Allopurinol) Has Been Accepted For FDA Review 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
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
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
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
Tesaro (TSRO) Announces Submission Of Niraparib New Drug Application For Platinum-Sensitive, Recurrent Ovarian Cancer 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



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