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Clinical - BLA/NDA/ANDA
Plant Problems Lead The FDA To Reject Pfizer (PFE)'s Epogen Biosimilar Again 6/23/2017
Novo Nordisk A/S (NVO): CHMP Adopts Positive Opinion For EU Label Update Of Victoza Based On The LEADER Trial 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
Bay Area's Coherus Craters After the FDA Spurns Its Biosimilar for Amgen (AMGN)'s Neulasta 6/13/2017
Braeburn Pharma And Knight Therapeutics Announce Filing Of New Drug Submission For PROBUPHINE In Canada For Opioid Drug Dependence 6/13/2017
Hutchison China MediTech (Chi-Med) Submits New Drug Application To CFDA For Fruquintinib In Advanced Colorectal Cancer 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
Bioverativ (BIVV) Announces FDA Acceptance Of Investigational New Drug Application For BIVV001 To Treat Hemophilia A 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
Why June Could be a Pivotal Month for These 2 Biotechs 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
Evoke Pharma (EVOK) Enters Agreement With Rho To Submit NDA For Gimoti 5/31/2017
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
TaiGen Biotechnology Announces Submission Of New Drug Application For Taigexyn Intravenous Formulation To The China Food And Drug Administration 5/30/2017
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
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
There’s A Therapeutic Curveball Heading For The FDA 5/25/2017
Puma Biotech (PBYI) Defies Odds, Wins FDA Backing for Breast Cancer Drug 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
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
Churchill Pharmaceuticals Announces Submission Of NDA For Novel Oral Formulation Of Prostate Cancer Treatment 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
XBiotech (XBIT) Sinks To A New Low After The EMA Rejects Lead Drug 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
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
Turmoil Hits As TherapeuticsMD (TXMD)'s Vaginal Pain Drug Gets Rejected By The FDA 5/8/2017
Conspiracy Theory: Did Puma Biotech (PBYI) Exec Resign Because of Bad News Ahead? 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
Eli Lilly (LLY) Gives No New Information On Rheumatoid Arthritis Drug Delay 4/26/2017
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
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
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
Vernalis PLC (VNLPY.PK): FDA Issues A Complete Response Letter On CCP-07 NDA 4/24/2017
Vernalis PLC (VNLPY.PK) Tanks After the FDA Spurns Cough-Cold Drug Filing 4/21/2017
XBiotech (XBIT) Craters After Disappointing EMA Meeting 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
FDA Just Rejected Eli Lilly (LLY), Incyte (INCY)'s Rheumatoid Arthritis Drug Baricitinib 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
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
AMAG (AMAG) Submits Supplemental New Drug Application To FDA For Makena (Hydroxyprogesterone Caproate Injection) Auto-Injector For Subcutaneous Use 4/17/2017
Puma Biotech (PBYI) Announces FDA Advisory Committee To Review Neratinib For The Extended Adjuvant Treatment Of HER2-Positive Early Stage Breast Cancer 4/17/2017
Icon Bioscience Submits NDA For DEXYCU, A Potential Transformational Drug Therapy For Treating Inflammation Associated With Cataract Surgery 4/13/2017
ArQule (ARQL) Receives Clearance Of Investigational New Drug Application From The FDA For Proprietary Reversible BTK Inhibitor, ARQ 531 4/11/2017
Agile Therapeutics, Inc. Announces Results Of Its Pre-Submission Meeting With FDA 4/11/2017
These 3 Big Biotechs Could Have New Blockbuster Drugs Very Soon 4/10/2017
TherapeuticsMD (TXMD) Provides TX-004HR Regulatory Update 4/10/2017
FDA Spurns Merck & Co. (MRK)'s Apps to Add Heart Data on Diabetes Drug Labels 4/7/2017
Acerus (TRLPF) Announces NATESTO Regulatory Filing in South Korea 4/6/2017
KaloBios (KBIO) Release: Benznidazole On Track In Progress To IND And NDA Submissions 4/6/2017
ProMetic Life Sci (PFSCF.PK) Completes The Filing Of Its Plasminogen Biologics License Application ("BLA") With The U.S. FDA 4/5/2017
China FDA Accepts JHL Biotech's First Clinical Trial Application 4/5/2017
FDA Accepts For Priority Review Bristol-Myers Squibb (BMY)’s Application For Opdivo (Nivolumab) In Previously Treated Dmmr Or MSI-H Metastatic Colorectal Cancer 4/5/2017
ViaDerma Enters The Sexual Dysfunction Market & Files With The FDA For A New OTC Drug To Conquer Premature Ejaculation For Men 4/5/2017
Janssen R&D Release: U.S. FDA Accepts For Review The Application Of Ibrutinib (IMBRUVICA) For Chronic Graft-Versus-Host-Disease (Cgvhd) After Failure Of One Or More Lines Of Systemic Therapy 4/4/2017
AbbVie (ABBV) Announces Ibrutinib (IMBRUVICA) Supplemental New Drug Application For Previously Treated Chronic Graft-Versus-Host-Disease (Cgvhd) Accepted For Review By U.S. FDA 4/4/2017
Celgene (CELG) Notified Of ANDA Filing For POMALYST 4/4/2017
Kadmon Submits Second Abbreviated New Drug Application Filing For Trientine Hydrochloride To FDA 4/4/2017
Elite Pharma (ELI) Files ANDA For Pain Product 4/4/2017
Novartis AG (NVS) Looks Over Its Shoulder as Kite Pharma (KITE) Hits Its BLA Filing Deadline 4/3/2017
Jazz Pharma (JAZZ) Completes Rolling Submission Of New Drug Application For Vyxeos (CPX-351), An Investigational Treatment For Acute Myeloid Leukemia 4/3/2017
Audentes (BOLD) Announces FDA Clearance Of Investigational New Drug Application For AT132 To Treat X-Linked Myotubular Myopathy 4/3/2017
U.S. FDA Grants Kitov (KTOV) A Waiver For New Drug Application Filing Fee 4/3/2017
Kite Pharma (KITE) Presents Ongoing Response Rate In Plenary Session From Its Pivotal CAR-T Trial Of Axicabtagene Ciloleucel In Patients With Aggressive Non-Hodgkin Lymphoma At The 2017 AACRh Annual Meeting 4/3/2017
Dynavax (DVAX) Announces FDA Advisory Committee Meeting To Review HEPLISAV-B 4/3/2017
Novartis AG (NVS) Jumps Into the Front of the CAR-T Line With Speedy Review of New Leukemia Drug 3/30/2017
Patheon (PTHN) Achieved More Outsourced New Drug Approvals Than Any Other Provider According To 2017 PharmSource CMO Scorecard 3/30/2017
AEterna Zentaris (AEZS) Intends To File NDA With Respect To Macrilen In Third Quarter Of 2017 3/30/2017
FDA Grants Priority Review For Amgen (AMGN)'s BLINCYTO (Blinatumomab) Supplemental Biologics License Application 3/30/2017
FDA Advisory Committee Unanimously Recommends Approval Of Genentech (RHHBY)’s Subcutaneous Rituximab For Certain Blood Cancers 3/29/2017
Innocoll (INNL) Announces Regulatory Path Forward After Receiving Formal FDA Type A Meeting Minutes Regarding Its XARACOLL (Bupivacaine Hcl Collagen-Matrix Implant) New Drug Application 3/29/2017
Nymox (NYMX) Provides Update On Fexapotide Development 3/29/2017
Mylan (MYL) Comments On Generic Advair Diskus Abbreviated New Drug Application 3/29/2017
AstraZeneca PLC (AZN) Shares Progress On LYNPARZA (Olaparib) Tablets In The U.S. 3/28/2017
FDA Grants Priority Review For Eagle Pharma (EGRX)’ Ryanodex NDA For The Treatment Of Exertional Heat Stroke 3/27/2017
Synergy Pharma (SGYP) Submits Supplemental New Drug Application (sNDA) For TRULANCE (Plecanatide) For The Treatment Of Adults With Irritable Bowel Syndrome With Constipation (IBS-C) 3/27/2017
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
FDA Deals Another Blow to AstraZeneca PLC (AZN)'s Blood Drug 3/20/2017
Array BioPharma (ARRY) Withdraws Skin Cancer NDA for Binimetinib 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
Immune Therapeutics Clears Critical Regulatory Hurdle For Lodonal In Kenya 3/17/2017
Agile Therapeutics, Inc. Announces A Poster Presentation Of Its SECURE Phase III Study At The Contraceptive Technology 2017 Conference 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
Radius Health (RDUS) Falls on PDUFA Extension for Abaloparatide-SC 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
NicOx SA (COX.PA) Resubmits AC-170 (ZERVIATE) NDA To The FDA 3/9/2017
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
Keryx (KERX) Announces U.S. FDA Filing Acceptance Of Supplemental New Drug Application For Auryxia (Ferric Citrate) Tablets 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
9 Massachusetts Biotechs Facing Major FDA Decisions This Year 3/3/2017
3 Top Biotechs Facing Make-or-Break FDA Decisions This Year 3/3/2017
10 Biotechs With an Orphan Drug in Late-Stage Pipeline 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
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
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
Melinta Announces FDA Acceptance of Investigational New Drug Application for Topical Radezolid 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
FDA Denies Amphastar (AMPH)'s Nasal Opioid Overdose Treatment 2/21/2017
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
U.S. FDA Accepts Biologics License Application (BLA) For Mylan (MYL) And BioCon (BIOCON.NS)'s Proposed Biosimilar Pegfilgrastim For Review 2/16/2017
Allergan (AGN) R&D Chief Reveals 6 Drugs That Could be Potential Blockbusters 2/14/2017
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
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