New Drug Applications Archive for 2025

January 2, 2025

• Capricor Therapeutics Completes Submission of Biologics License Application to the U.S. FDA for Deramiocel for the Treatment of Duchenne Muscular Dystrophy

January 7, 2025

• U.S. FDA Granted Priority Review to Dizal's Sunvozertinib New Drug Application

January 16, 2025

• Atara Biotherapeutics Provides Regulatory and Business Update on Ebvallo (tabelecleucel)

January 17, 2025

• Arrowhead Pharmaceuticals Announces Acceptance of New Drug Application by U.S. FDA of Plozasiran for the Treatment of Familial Chylomicronemia Syndrome

January 23, 2025

• Stealth BioTherapeutics Announces PDUFA Action Date Extension for Elamipretide to Treat Patients with Barth Syndrome

January 28, 2025

• Saol Therapeutics Announces FDA Acceptance of New Drug Application for SL1009 for Treatment of Pyruvate Dehydrogenase Complex Deficiency

January 29, 2025

• Scholar Rock Submits Biologics License Application (BLA) to the U.S. FDA for Apitegromab as a Treatment for Patients with Spinal Muscular Atrophy (SMA)

February 6, 2025

• Eton Pharmaceuticals Announces Extension of PDUFA Goal Date for ET-400
• FDA Grants Priority Review to Insmed's Brensocatib for Treatment of Bronchiectasis with PDUFA Target Action Date Set for August 12, 2025

February 10, 2025

• LIB Therapeutics Announces FDA Acceptance of Biologics License Application for Lerodalcibep to Lower LDL-Cholesterol Across Broad Patient Population

February 11, 2025

• Linvoseltamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Multiple Myeloma
• Biohaven Announces FDA Acceptance and Priority Review of Troriluzole New Drug Application for the Treatment of Spinocerebellar Ataxia

February 18, 2025

• Chimerix Announces FDA Acceptance and Priority Review of New Drug Application for Dordaviprone as Treatment for Recurrent H3 K27M-Mutant Diffuse Glioma

February 19, 2025

• PTC Therapeutics Announces FDA Acceptance and Priority Review for Vatiquinone NDA for the Treatment of Children and Adults with Friedreich's Ataxia

February 26, 2025

• Odronextamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Follicular Lymphoma

March 3, 2025

• FDA Files Corcept’s New Drug Application for Relacorilant as Treatment for Patients With Hypercortisolism
• Depemokimab Applications Accepted for Review by the US FDA for Asthma with Type 2 Inflammation and for Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

March 4, 2025

• Capricor Therapeutics Announces FDA Acceptance and Priority Review of its Biologics License Application for Deramiocel to Treat Duchenne Muscular Dystrophy

March 25, 2025

• Tolebrutinib Regulatory Submission Accepted for Priority Review in the US for Patients with Multiple Sclerosis
• FDA Grants Priority Review for Biologics License Application (BLA) for Apitegromab as a Treatment for Spinal Muscular Atrophy

March 28, 2025

• FDA Issues Complete Response Letter for Etripamil for PSVT

March 31, 2025

• Otsuka Files Biologics License Application (BLA) for Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy
• Vanda Pharmaceuticals Announces the Submission of an NDA to the FDA for Bysanti for the Treatments of Acute Bipolar I Disorder and Schizophrenia

April 3, 2025

• Aldeyra Therapeutics Receives Complete Response Letter from the U.S. Food and Drug Administration for the Reproxalap New Drug Application for the Treatment of Signs and Symptoms of Dry Eye Disease