FDA Approves Sunlenca (lenacapavir) Twice-Yearly Treatment for People Living With Multi-Drug Resistant HIV
Sunlenca is the First and Only Approved Capsid Inhibitor-Based HIV Treatment Option New Drug Application Approval Based on High Rates of Sustained Virologic Suppression in the CAPELLA Trial FOSTER CITY, Calif.--(BUSINESS WIRE) December... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 22, 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

Idorsia submits a new drug application to the FDA By Reuters
Idorsia submits a new drug application to the FDA ZURICH (Reuters) - Swiss biotech company Idorsia has submitted a new application for approval of the drug aprocitentan to the U.S. Food and Drug Administration. Aprocitentan is intended to be used in the treatment of patients with…#idorsia #aprocitentan #fda (Source: Reuters: Health)
Source: Reuters: Health - December 20, 2022 Category: Consumer Health News 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

Malvern-based Galera shares rise on FDA filing for lead cancer therapy drug
Shares of Chester County biopharmaceutical company developing new cancer therapies opened up 9% Monday after filing its first new drug application with the Food and Drug Administration. Galera Therapeutics (NASDAQ: GRTX) of Malvern is seeking approval for avasopasem as a treatment for radiotherapy-induced severe oral mucositis in patients with head and neck cancer. There are no FDA-approved treatment for severe oral mucositis. The condition can result in patients developing painful ulcers in the … (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - December 12, 2022 Category: American Health Authors: John George 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

Ocuphire Pharma Announces Submission of New Drug Application to FDA for Nyxol Eye Drops for Reversal of Mydriasis
NDA Supported by Positive Phase 3 Data Demonstrating Rapid Reversal of Dilated Eyes and Favorable Safety Profile in Pediatric and Adult Subjects FARMINGTON HILLS, Mich., Dec. 06, 2022 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 6, 2022 Category: Drugs & Pharmacology Source Type: news