Minerva Neurosciences Announces Update on its New Drug Application (NDA) for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia
BURLINGTON, Mass., Dec. 28, 2022 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 28, 2022 Category: Drugs & Pharmacology Source Type: news
SpringWorks Therapeutics Completes Submission of New Drug Application to the FDA for Nirogacestat for the Treatment of Adults with Desmoid Tumors
STAMFORD, Conn., Dec. 27, 2022 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, announced... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 27, 2022 Category: Drugs & Pharmacology Source Type: news
Ipsen Receives Complete Response Letter for Palovarotene, an Investigational Treatment for Fibrodysplasia Ossificans Progressiva
The CRL is related to the U.S. FDA’s previous request for additional information on palovarotene clinical trial data
Ipsen anticipates responding to the request in the first quarter of 2023
PARIS, FRANCE, 23 December 2022– The... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 23, 2022 Category: Drugs & Pharmacology Source Type: news
Valneva Completes BLA Submission to U.S. FDA for its Single-Shot Chikungunya Vaccine Candidate
Saint-Herblain (France), December 23, 2022– Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces that it has completed rolling submission of the Biologics License Application (BLA) to the U.S. Food and... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 23, 2022 Category: Drugs & Pharmacology Source Type: news
Pfizer Announces FDA and EMA Acceptance of Etrasimod Regulatory Submissions for Ulcerative Colitis
Filings based on two Phase 3 trials demonstrating significant clinical remission versus placebo and safety profile consistent with previous studies
NEW YORK--(BUSINESS WIRE) December 21, 2022 -- Pfizer Inc. (NYSE: PFE) announced today that the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 21, 2022 Category: Drugs & Pharmacology Source Type: news
Iveric Bio Announces Completion of Rolling NDA Submission to FDA for Avacincaptad Pegol for the Treatment of Geographic Atrophy
PARSIPPANY, N.J.--(BUSINESS WIRE)--Dec. 20, 2022-- IVERIC bio, Inc. (Nasdaq: ISEE) today announced that it has submitted to the U.S. Food and Drug Administration (FDA) the third and final part of its New Drug Application (NDA) for rolling review of... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 20, 2022 Category: Drugs & Pharmacology Source Type: news
Idorsia Submits a New Drug Application to the US FDA for Aprocitentan for the Treatment of Patients with Difficult-to-Control Hypertension
The application includes data from the Phase 3 registration study of patients with resistant hypertension, where aprocitentan demonstrated a sustained blood pressure reduction over 48 weeks and was well-tolerated
Allschwil, Switzerland–... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 20, 2022 Category: Drugs & Pharmacology Source Type: news
F2G Announces FDA Filing Acceptance Of New Drug Application For Olorofim For The Treatment Of Invasive Fungal Infections
PRINCETON, N.J., Dec. 19, 2022 (GLOBE NEWSWIRE) -- F2G Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for olorofim for the treatment of invasive fungal infections in... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 19, 2022 Category: Drugs & Pharmacology Source Type: news
Cytokinetics Announces Outcome of FDA Advisory Committee Vote On Omecamtiv Mecarbil
PDUFA Target Action Date is February 28, 2023
SOUTH SAN FRANCISCO, Calif., Dec. 13, 2022 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food& Drug Administration (FDA) Cardiovascular and Renal... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 13, 2022 Category: Drugs & Pharmacology Source Type: news
Eyenovia Announces FDA Acceptance of New Drug Application for MydCombi ™ for In-Office Pupil Dilation
NEW YORK, Dec. 13, 2022 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a pre-commercial ophthalmic technology company developing the Optejet® delivery system for use both in connection with its own drug-device therapeutic programs for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 13, 2022 Category: Drugs & Pharmacology Source Type: news
Galera Submits New Drug Application for Avasopasem for Severe Oral Mucositis
MALVERN, Pa., Dec. 12, 2022 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 12, 2022 Category: Drugs & Pharmacology Source Type: news
Janssen Submits Biologics License Application to U.S. FDA for Talquetamab for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
RARITAN, N.J., December 9, 2022– The Janssen Pharmaceutical Companies of Johnson& Johnson today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for talquetamab for the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 9, 2022 Category: Drugs & Pharmacology Source Type: news
FDA Accepts Braeburn's New Drug Application Resubmission for Brixadi (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder
Prescription Drug User Fee Act (PDUFA) action date set for May 23, 2023.
Plymouth Meeting, Pa.—December 8, 2022—Braeburn announces that the New Drug Application (NDA) for BRIXADI (buprenorphine) extended-release weekly and monthly... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 8, 2022 Category: Drugs & Pharmacology Source Type: news
Visiox Pharma Announces FDA Acceptance of New Drug Application for Glaucoma
TARRYTOWN, N.Y., Dec. 8, 2022 /PRNewswire/ -- Visiox Pharma, LLC., a privately funded biopharmaceutical company focused on the development and commercialization of ophthalmic drugs to address highly prevalent diseases in need of new treatment... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 8, 2022 Category: Drugs & Pharmacology Source Type: news
Biogen and Sage Therapeutics Complete Rolling Submission of New Drug Application for Zuranolone in the Treatment of Major Depressive Disorder and Postpartum Depression
Zuranolone is being evaluated as a short course, rapid-acting, oral medication for major depressive disorder (MDD) and postpartum depression (PPD)
Cambridge, Mass.– Dec. 6, 2022– Biogen Inc. (Nasdaq: BIIB) and Sage Therapeutics... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 6, 2022 Category: Drugs & Pharmacology Source Type: news
