Evoke Pharma ’s Gimoti NDA Accepted for FDA Review
SOLANA BEACH, Calif., Aug. 16, 2018 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that the Company ’s 505(b)(2) New Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 16, 2018 Category: Drugs & Pharmacology Source Type: news

Motif Bio Announces FDA Acceptance of New Drug Application With Priority Review for Iclaprim for Treatment of Acute Bacterial Skin and Skin Structure Infections
NEW YORK, Aug. 14, 2018 (GLOBE NEWSWIRE) -- Motif Bio plc (AIM/NASDAQ: MTFB), a clinical-stage biopharmaceutical company specialising in developing novel antibiotics, today announced that the U.S. Food& Drug Administration (FDA) has accepted... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 14, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Accepts New Drug Application (NDA) to Review Midazolam Nasal Spray, an Investigational Product for the Acute Treatment of Seizure Clusters
Brussels (Belgium)& Atlanta Georgia, August 13th 07:00 (CEST): UCB today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of a New Drug Application (NDA) for midazolam nasal spray*, an investigational product... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 13, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Advisory Committee Recommends Approval of Paratek ’s Omadacycline
BOSTON, Aug. 08, 2018 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ: PRTK) today announced that the Antimicrobials Drug Advisory Committee of the U.S. Food and Drug Administration voted in favor of the approval of intravenous (IV) and... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 8, 2018 Category: Drugs & Pharmacology Source Type: news

Complete Response Letter Issued for Remoxy
AUSTIN, Texas, Aug. 06, 2018 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq: PTIE) today announced it had received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for Remoxy,... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 6, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Accepts File for Cladribine Tablets as Potential Treatment for Relapsing Forms of Multiple Sclerosis
ROCKLAND, Mass., July 30, 2018 /PRNewswire/ -- EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced that a resubmission of the New Drug Application (NDA) for cladribine tablets as a... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 30, 2018 Category: Drugs & Pharmacology Source Type: news

Nektar Therapeutics Announces New Drug Application for NKTR-181 Accepted for Review by FDA
SAN FRANCISCO, July 30, 2018 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today announced that the U.S. Food and Drug Administration (FDA) has filed and accepted for review the company's New Drug Application (NDA) for NKTR-181 for the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 30, 2018 Category: Drugs & Pharmacology Source Type: news

INSYS Therapeutics Receives Complete Response Letter from FDA for Buprenorphine NDA
PHOENIX, July 27, 2018 (GLOBE NEWSWIRE) -- INSYS Therapeutics, Inc. (NASDAQ: INSY) announced that today it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the company ’s New Drug Application... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 27, 2018 Category: Drugs & Pharmacology Source Type: news

Karyopharm Initiates Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Selinexor as a Treatment for Patients with Penta-Refractory Multiple Myeloma
NEWTON, Mass., July 18, 2018 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today announced that the Company has initiated a rolling submission of a New Drug Application (NDA) to the U.S.... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 18, 2018 Category: Drugs & Pharmacology Source Type: news

Camurus Announces PDUFA Date for CAM2038 for the Treatment of Opioid Use Disorder
Lund, Sweden – 16 July 2018 — Camurus (NASDAQ STO: CAMX) announced today that the US Food and Drug Administration (FDA) assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 26, 2018 for its investigational weekly and monthly... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 16, 2018 Category: Drugs & Pharmacology Source Type: news

Amgen And UCB Resubmit Biologics License Application (BLA) For Evenity (romosozumab) To The US FDA
THOUSAND OAKS, Calif. and BRUSSELS, July 12, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced the resubmission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 12, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Advisory Committee Endorses the Effectiveness and Safety of Single-Dose Tafenoquine for the Radical Cure of P. vivax Malaria
London UK; Philadelphia US; Geneva, Switzerland - 12 July 2018 - GSK and Medicines for Malaria Venture (MMV) today announced that the Antimicrobial Drugs Advisory Committee (AMDAC) of the United States Food and Drug Administration (FDA) voted that... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 12, 2018 Category: Drugs & Pharmacology Source Type: news

Ocular Therapeutix Announces NDA Resubmission of Dextenza
BEDFORD, Mass.--(BUSINESS WIRE)--Jun. 29, 2018-- Ocular Therapeutix ™, Inc. (NASDAQ: OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye,... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 29, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Grants Priority Review for Pfizer ’s New Drug Application for Glasdegib in Patients with Previously Untreated Acute Myeloid Leukemia
June 27, 2018 - Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted the company ’s New Drug Application and granted Priority Review designation for glasdegib, an investigational oral smoothened (SMO)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 27, 2018 Category: Drugs & Pharmacology Source Type: news

Pain Therapeutics Announces Results of FDA Advisory Committee Meeting for Remoxy ER
AUSTIN, Texas, June 26, 2018 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE), a drug development company, today announced that a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 26, 2018 Category: Drugs & Pharmacology Source Type: news

Historic New Drug Application for the use of Scenesse (afamelanotide) in Rare Metabolic Disorder Erythropoietic Protoporphyria (EPP)
Monday, 25 June 2018 -- Clinuvel Pharmaceuticals Ltd. today announced that it has completed the submission of a New Drug Application (NDA) for its drug Scenesse (afamelanotide 16 mg) as the first proposed therapy for patients with the rare metabolic... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 25, 2018 Category: Drugs & Pharmacology Source Type: news

Alexion Submits Application for Priority Review and Approval of ALXN1210 as a Treatment for Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) in the U.S.
NEW HAVEN, Conn.--(BUSINESS WIRE) June 19, 2018 --Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of ALXN1210, the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 19, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Issues Complete Response Letter for Duobrii (halobetasol propionate and tazarotene) Lotion
LAVAL, Quebec, June 18, 2018 /PRNewswire/ -- Ortho Dermatologics, a division of Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX), today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 18, 2018 Category: Drugs & Pharmacology Source Type: news

Motif Bio Submits NDA for Iclaprim
NEW YORK, June 14, 2018 (GLOBE NEWSWIRE) -- Motif Bio plc (AIM:MTFB) (NASDAQ:MTFB), a clinical-stage biopharmaceutical company specialising in developing novel antibiotics, today announced the completion of its rolling submission of a New Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 14, 2018 Category: Drugs & Pharmacology Source Type: news

Sunovion Announces FDA Acceptance of New Drug Application for Apomorphine Sublingual Film (APL-130277)
MARLBOROUGH, Mass.--(BUSINESS WIRE) June 12, 2018 --Sunovion Pharmaceuticals Inc. (Sunovion) announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for apomorphine sublingual film (APL-130277) to... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 12, 2018 Category: Drugs & Pharmacology Source Type: news

U.S. FDA and European Medicines Agency Accept Regulatory Submissions for Review of Talazoparib for Metastatic Breast Cancer Patients with an Inherited BRCA Mutation
June 7, 2018 - Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration accepted for filing and granted Priority Review designation to the company ’s New Drug Application for talazoparib. The submission is based on results... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 7, 2018 Category: Drugs & Pharmacology Source Type: news

Intra-Cellular Therapies Initiates Rolling Submission of New Drug Application for Lumateperone for Treatment of Schizophrenia
NEW YORK, June 06, 2018 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced the initiation of a rolling... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 6, 2018 Category: Drugs & Pharmacology Source Type: news

Evoke Announces FDA Submission of New Drug Application for Gimoti
SOLANA BEACH, Calif., June 04, 2018 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced the submission of its 505(b)(2) New Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 4, 2018 Category: Drugs & Pharmacology Source Type: news

Palatin Technologies Announces FDA Acceptance for Review of Bremelanotide NDA
CRANBURY, N.J., June 4, 2018 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical needs... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 4, 2018 Category: Drugs & Pharmacology Source Type: news

Circassia Announces Submission of Duaklir (aclidinium and formoterol) New Drug Application
Oxford, UK – 1 June 2018 Circassia Pharmaceuticals plc (“Circassia” or “the Company”; LSE: CIR), a specialty pharmaceutical company focused on respiratory disease, today announces the submission of a New Drug Application (NDA) to the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 1, 2018 Category: Drugs & Pharmacology Source Type: news

Sage Therapeutics Announces FDA Acceptance of NDA Filing and Grant of Priority Review for Brexanolone IV in the Treatment of Postpartum Depression
CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 30, 2018-- Sage Therapeutics (NASDAQ: SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced that the U.S.... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 30, 2018 Category: Drugs & Pharmacology Source Type: news

Kyowa Hakko Kirin Announces FDA Notification of PDUFA Action Date Extension for Mogamulizumab
Tokyo, Japan, May 30, 2018 –Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151 President and COO: Masashi Miyamoto, “Kyowa Hakko Kirin”) announced today that it has been notified that the U.S. Food and Drug Administration (FDA) is extending its review... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 30, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Accepts Larotrectinib New Drug Application and Grants Priority Review
WHIPPANY, N.J., May 29, 2018 /PRNewswire/ -- Bayer announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) submitted by its collaboration partner Loxo Oncology, Inc. (NASDAQ: LOXO), and granted... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 29, 2018 Category: Drugs & Pharmacology Source Type: news

U.S. FDA Grants Priority Review to Astellas' New Drug Application for Gilteritinib for the Treatment of Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML)
TOKYO, May 29, 2018 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D. " Astellas " ) announced today that the U.S. Food and Drug Administration (FDA) has accepted, with Priority Review, the company's New Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 29, 2018 Category: Drugs & Pharmacology Source Type: news

Braeburn Resubmits New Drug Application for CAM2038 for Opioid Use Disorder
Plymouth Meeting, Pa. —May 28, 2018 — Braeburn announces the resubmission of the New Drug Application (NDA) for CAM2038, an investigational buprenorphine flexible-dose weekly and monthly depot injection for the treatment of opioid use disorder... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 28, 2018 Category: Drugs & Pharmacology Source Type: news

AcelRx Announces FDA Acceptance of NDA for DSUVIA
REDWOOD CITY, Calif., May 24, 2018 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx or the Company), a specialty pharmaceutical company focused on innovative therapies for use in medically supervised settings, today announced the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 24, 2018 Category: Drugs & Pharmacology Source Type: news

Teva Confirms September PDUFA Date for Fremanezumab
JERUSALEM--(BUSINESS WIRE)--May 23, 2018-- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today confirmed that the U.S. Food and Drug Administration (FDA) has extended the goal date of the Biologics License Application (BLA) for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 23, 2018 Category: Drugs & Pharmacology Source Type: news

INSYS Therapeutics Confirms Outcome of FDA Advisory Committee Meeting on Buprenorphine Sublingual Spray
PHOENIX, May 22, 2018 (GLOBE NEWSWIRE) -- INSYS Therapeutics, Inc. (NASDAQ:INSY), a leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology, confirmed today that an expert panel convened by... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 22, 2018 Category: Drugs & Pharmacology Source Type: news

FDA to Review Zynquista (sotagliflozin) as Potential Treatment for Type 1 Diabetes
BRIDGEWATER, N.J. and THE WOODLANDS, Texas, May 22, 2018 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has accepted Sanofi's regulatory filing for Zynquista (sotagliflozin). The investigational oral treatment would be used in addition... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 22, 2018 Category: Drugs & Pharmacology Source Type: news

Glenmark Pharmaceuticals Announces the Company's First NDA for Ryaltris for Patients with Seasonal Allergic Rhinitis
MAHWAH, N.J., May 21, 2018 /PRNewswire/ -- Glenmark Pharmaceuticals, a global pharmaceutical company, today announced that the company has submitted a New Drug Application (NDA) to the U.S. Food& Drug Administration (FDA) for its leading... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 21, 2018 Category: Drugs & Pharmacology Source Type: news

Agile Therapeutics, Inc. Provides Regulatory Update on Twirla (AG200-15) for the Prevention of Pregnancy
PRINCETON, N.J., May 18, 2018 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc., (Nasdaq:AGRX), a women's healthcare company, today announced the content of the official minutes from its Type A meeting with the U.S. Food and Drug Administration (FDA)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 18, 2018 Category: Drugs & Pharmacology Source Type: news

Aerie Pharmaceuticals Submits NDA to FDA for Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%
DURHAM, N.C.--(BUSINESS WIRE)--May 15, 2018-- Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 15, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Advisory Committee Votes in Favor of Waylivra (volanesorsen) for Treatment of Familial Chylomicronemia Syndrome
CAMBRIDGE, Mass. and CARLSBAD, Calif., May 10, 2018 (GLOBE NEWSWIRE) -- Akcea Therapeutics, Inc. (NASDAQ:AKCA), an affiliate of Ionis Pharmaceuticals, Inc., and Ionis Pharmaceuticals, Inc. (NASDAQ:IONS) today announced that the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 10, 2018 Category: Drugs & Pharmacology Source Type: news

AcelRx Resubmits New Drug Application for DSUVIA
REDWOOD CITY, Calif., May 9, 2018 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx or the Company), a specialty pharmaceutical company focused on innovative therapies for use in medically supervised settings, today announced the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 9, 2018 Category: Drugs & Pharmacology Source Type: news

Lipocine Receives Complete Response Letter for Tlando From U.S. Food and Drug Administration
SALT LAKE CITY, May 9, 2018 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company, announced today that it has received a Complete Response Letter ( " CRL " ) from the United States Food and Drug Administration ( " FDA " )... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 9, 2018 Category: Drugs & Pharmacology Source Type: news

Mallinckrodt Reports on FDA Joint Advisory Committee Meeting for Stannsoporfin for the Treatment of Newborns at Risk of Developing Severe Jaundice
STAINES-UPON-THAMES, United Kingdom, May 3, 2018 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, today expressed disappointment that, in a joint meeting, the U.S. Food and Drug Administration's... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 3, 2018 Category: Drugs & Pharmacology Source Type: news

Achaogen Announces FDA Advisory Committee Voted Unanimously in Favor of Plazomicin for Treatment of Adults with Complicated Urinary Tract Infections
SOUTH SAN FRANCISCO, Calif., May 02, 2018 (GLOBE NEWSWIRE) -- Achaogen, Inc. (NASDAQ:AKAO), a late-stage biopharmaceutical company developing innovative antibacterials addressing multi-drug resistant (MDR) gram-negative infections, today announced... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 2, 2018 Category: Drugs & Pharmacology Source Type: news

SIGA Technologies Announces Favorable Outcome of Advisory Committee In Support of TPOXX
NEW YORK, May 01, 2018 (GLOBE NEWSWIRE) -- SIGA Technologies, Inc. (SIGA) (NASDAQ:SIGA), a health security company specializing in the development and commercialization of solutions for serious unmet medical needs and biothreats, today announced a... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 1, 2018 Category: Drugs & Pharmacology Source Type: news

FDA to Conduct Priority Review of Cemiplimab as a Potential Treatment for Advanced Cutaneous Squamous Cell Carcinoma
PARIS and TARRYTOWN, N.Y., April 30, 2018 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for cemiplimab for the treatment of patients with metastatic cutaneous... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 30, 2018 Category: Drugs & Pharmacology Source Type: news

AbbVie Submits Biologics License Application to U.S. FDA for Investigational Treatment Risankizumab for Moderate to Severe Plaque Psoriasis
NORTH CHICAGO, Ill., April 25, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 25, 2018 Category: Drugs & Pharmacology Source Type: news

Astellas Submits New Drug Applications for Approval of Gilteritinib for the Treatment of FLT3mut+ Relapsed or Refractory Acute Myeloid Leukemia
TOKYO, April 23, 2018 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., " Astellas " ) today announced that it submitted on March 23, 2018, a new drug application (NDA) for marketing approval of gilteritinib... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 23, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Advisory Committee Recommends the Approval of Baricitinib 2mg, but not 4mg, for the Treatment of Moderately-to-Severely Active Rheumatoid Arthritis
INDIANAPOLIS, April 23, 2018 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that the U.S. Food and Drug Administration's (FDA) Arthritis Advisory Committee recommended approval of the 2-mg... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 23, 2018 Category: Drugs & Pharmacology Source Type: news

Sage Therapeutics Submits New Drug Application to U.S. FDA for Intravenous Brexanolone in the Treatment of Postpartum Depression
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Apr. 23, 2018-- Sage Therapeutics (NASDAQ: SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced the Company has... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 23, 2018 Category: Drugs & Pharmacology Source Type: news

Pfizer Granted FDA Breakthrough Therapy Designation for Trumenba (Meningococcal Group B Vaccine) for the Prevention of Invasive Meningococcal B Disease in Children Ages 1 to 9 Years
Monday, April 23, 2018 - Pfizer Inc. (NYSE: PFE) today announced that Trumenba (Meningococcal Group B Vaccine) received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for active immunization to prevent invasive... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 23, 2018 Category: Drugs & Pharmacology Source Type: news

Unanimous Positive Result of FDA Advisory Committee Meeting for First Plant-Based Pharmaceutical Cannabidiol Treatment for Seizures in Patients with Two Rare, Severe Forms of Epilepsy
LONDON and CARLSBAD, Calif., April 19, 2018 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (Nasdaq:GWPH) ( “GW”, “the Company” or “the Group”), a biopharmaceutical company focused on discovering, developing and commercializing novel... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 19, 2018 Category: Drugs & Pharmacology Source Type: news