New Drug Applications
Vanda Pharmaceuticals Announces the Submission of an NDA to the FDA for Bysanti for the Treatments of Acute Bipolar I Disorder and Schizophrenia
WASHINGTON, March 31, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced that a New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) requesting marketing approval of...-
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Pub Date: Mon, 31 Mar 2025 22:03:56 +0000
Otsuka Files Biologics License Application (BLA) for Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy
PRINCETON, N.J. and TOKYO, JAPAN March 31, 2025 – Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announce the filing of a Biologics License Application (BLA) with the U.S...-
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Pub Date: Mon, 31 Mar 2025 22:03:10 +0000
FDA Issues Complete Response Letter for Etripamil for PSVT
MONTREAL and CHARLOTTE, N.C., March 28, 2025 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) today announced the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding its New Drug...-
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Pub Date: Fri, 28 Mar 2025 21:03:35 +0000
FDA Grants Priority Review for Biologics License Application (BLA) for Apitegromab as a Treatment for Spinal Muscular Atrophy
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Mar. 25, 2025-- Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company focused on advancing innovative treatments for neuromuscular diseases, cardiometabolic disorders, and other serious diseases...-
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Pub Date: Tue, 25 Mar 2025 05:03:50 +0000
Tolebrutinib Regulatory Submission Accepted for Priority Review in the US for Patients with Multiple Sclerosis
Paris, March 25, 2025. The US Food and Drug Administration (FDA) is evaluating under priority review the regulatory submission of tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis (nrSPMS) and to slow disability...-
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Pub Date: Tue, 25 Mar 2025 04:03:13 +0000
Capricor Therapeutics Announces FDA Acceptance and Priority Review of its Biologics License Application for Deramiocel to Treat Duchenne Muscular Dystrophy
SAN DIEGO, March 04, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced the U.S. Food and Drug...-
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Pub Date: Tue, 04 Mar 2025 19:03:47 +0000
Depemokimab Applications Accepted for Review by the US FDA for Asthma with Type 2 Inflammation and for Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
London, UK -- 03 March 2025 -- GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application for the use of depemokimab in two indications. The proposed indications are...-
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Pub Date: Mon, 03 Mar 2025 21:03:16 +0000
FDA Files Corcept’s New Drug Application for Relacorilant as Treatment for Patients With Hypercortisolism
REDWOOD CITY, Calif.--(BUSINESS WIRE)--Mar. 3, 2025-- Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and...-
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Pub Date: Mon, 03 Mar 2025 03:03:07 +0000
Odronextamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Follicular Lymphoma
TARRYTOWN, N.Y., Feb. 26, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application...-
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Pub Date: Wed, 26 Feb 2025 05:02:24 +0000
PTC Therapeutics Announces FDA Acceptance and Priority Review for Vatiquinone NDA for the Treatment of Children and Adults with Friedreich's Ataxia
WARREN, N.J., Feb. 19, 2025 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for vatiquinone for the treatment of children...-
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Pub Date: Wed, 19 Feb 2025 00:02:55 +0000
Chimerix Announces FDA Acceptance and Priority Review of New Drug Application for Dordaviprone as Treatment for Recurrent H3 K27M-Mutant Diffuse Glioma
DURHAM, N.C., Feb. 18, 2025 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ: CMRX), a biopharmaceutical company whose mission it is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases, today announced the U.S...-
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Pub Date: Tue, 18 Feb 2025 03:02:07 +0000
Biohaven Announces FDA Acceptance and Priority Review of Troriluzole New Drug Application for the Treatment of Spinocerebellar Ataxia
NEW HAVEN, Conn., Feb. 11, 2025 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) (Biohaven or the Company), today announced that the US Food and Drug Administration (FDA) has accepted for review the Company's New Drug Application (NDA) for troriluzole for...-
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Pub Date: Tue, 11 Feb 2025 22:02:19 +0000
Linvoseltamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Multiple Myeloma
TARRYTOWN, N.Y., Feb. 11, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA)...-
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Pub Date: Tue, 11 Feb 2025 18:02:24 +0000
LIB Therapeutics Announces FDA Acceptance of Biologics License Application for Lerodalcibep to Lower LDL-Cholesterol Across Broad Patient Population
CINCINNATI- February 10, 2025 --LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company today announced the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) of...-
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Pub Date: Mon, 10 Feb 2025 19:02:46 +0000
FDA Grants Priority Review to Insmed's Brensocatib for Treatment of Bronchiectasis with PDUFA Target Action Date Set for August 12, 2025
BRIDGEWATER, N.J., Feb. 6, 2025 /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases...-
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Pub Date: Thu, 06 Feb 2025 23:02:09 +0000
Eton Pharmaceuticals Announces Extension of PDUFA Goal Date for ET-400
DEER PARK, Ill., Feb. 06, 2025 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare...-
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Pub Date: Thu, 06 Feb 2025 22:02:19 +0000
Scholar Rock Submits Biologics License Application (BLA) to the U.S. FDA for Apitegromab as a Treatment for Patients with Spinal Muscular Atrophy (SMA)
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 29, 2025-- Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company focused on advancing innovative treatments for spinal muscular atrophy (SMA), cardiometabolic disorders, and other serious...-
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Pub Date: Wed, 29 Jan 2025 04:01:25 +0000
Saol Therapeutics Announces FDA Acceptance of New Drug Application for SL1009 for Treatment of Pyruvate Dehydrogenase Complex Deficiency
ROSWELL, Ga, DUBLIN and HAMILTON, Bermuda, January 28, 2025 – Saol Therapeutics, a privately held, clinical-stage pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug...-
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Pub Date: Tue, 28 Jan 2025 01:01:47 +0000
Stealth BioTherapeutics Announces PDUFA Action Date Extension for Elamipretide to Treat Patients with Barth Syndrome
NEEDHAM, Mass., Jan. 23, 2025 /PRNewswire/ — Stealth BioTherapeutics Inc. (the “Company” or “Stealth”), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel...-
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Pub Date: Thu, 23 Jan 2025 18:01:39 +0000
Arrowhead Pharmaceuticals Announces Acceptance of New Drug Application by U.S. FDA of Plozasiran for the Treatment of Familial Chylomicronemia Syndrome
PASADENA, Calif.–(BUSINESS WIRE)–Jan. 17, 2025– Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for investigational...-
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Pub Date: Fri, 17 Jan 2025 20:01:57 +0000
Atara Biotherapeutics Provides Regulatory and Business Update on Ebvallo (tabelecleucel)
THOUSAND OAKS, Calif.--(BUSINESS WIRE) January 16, 2025 -- Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for...-
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Pub Date: Thu, 16 Jan 2025 02:01:03 +0000
U.S. FDA Granted Priority Review to Dizal's Sunvozertinib New Drug Application
SHANGHAI, Jan. 7, 2025 /PRNewswire/ -- Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announced that the U.S. Food and Drug Administration (FDA) has...-
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Pub Date: Tue, 07 Jan 2025 03:01:30 +0000
Capricor Therapeutics Completes Submission of Biologics License Application to the U.S. FDA for Deramiocel for the Treatment of Duchenne Muscular Dystrophy
SAN DIEGO, Jan. 02, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced the completion of the...-
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Pub Date: Thu, 02 Jan 2025 22:01:49 +0000
Verastem Oncology Announces FDA Acceptance and Priority Review of New Drug Application for Avutometinib in Combination with Defactinib for the Treatment of Recurrent KRAS Mutant Low-Grade Serous Ovarian Cancer
BOSTON--(BUSINESS WIRE)--Dec. 30, 2024-- Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today announced that the U.S. Food and Drug Administration (FDA) has accepted for...-
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Pub Date: Mon, 30 Dec 2024 23:12:09 +0000
NRx Pharmaceuticals, Inc. Files Initial Section of U.S. New Drug Application to the FDA for NRX-100 (IV Ketamine) for the Treatment of Suicidal Depression
WILMINGTON, Del., Dec. 30, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx", the "Company"), a clinical-stage biopharmaceutical company, today announced the transmission of first section of its New Drug Application (NDA) for...-
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Pub Date: Mon, 30 Dec 2024 22:12:47 +0000