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 6, 2025

• Sentynl Therapeutics Announces U.S. FDA Acceptance and Priority Review of New Drug Application for CUTX-101 (Copper Histidinate) Product Candidate for Treatment of Menkes Disease

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

April 8, 2025

• Kura Oncology and Kyowa Kirin Announce Submission of New Drug Application for Ziftomenib to FDA
• Tenpoint Therapeutics Ltd. Submits New Drug Application to U.S. FDA for Brimochol PF for the Treatment of Presbyopia

April 29, 2025

• Stealth BioTherapeutics Announces Delay in FDA Action Date for Barth Syndrome Application for Elamipretide

May 1, 2025

• Cytokinetics Announces New PDUFA Date for Aficamten in Obstructive Hypertrophic Cardiomyopathy

May 5, 2025

• Vanda Announces Bysanti NDA Filing; FDA Decision Expected in Early 2026

May 14, 2025

• FDA Extends PDUFA Date of Biohaven's Troriluzole NDA for Rare Disease Spinocerebellar Ataxia

May 27, 2025

• Otsuka Announces FDA Acceptance and Priority Review of Biologics License Application (BLA) for Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy (IgAN)

May 29, 2025

• Patritumab Deruxtecan Biologics License Application for Patients with Previously Treated Locally Advanced or Metastatic EGFRMutated Non-Small Cell Lung Cancer Voluntarily Withdrawn
• Stealth BioTherapeutics Announces “Path Forward” Despite Disappointing Delay for Ultra-Rare Barth Syndrome
• U.S. FDA Accepts New Drug Application Under Priority Review for Sevabertinib (BAY 2927088) in HER2-Mutant Non-Small Cell Lung Cancer

June 1, 2025

• Kura Oncology and Kyowa Kirin Announce FDA Acceptance and Priority Review of New Drug Application for Ziftomenib in Adults with Relapsed or Refractory NPM1-Mutant AML

June 2, 2025

• Linerixibat New Drug Application (NDA) Accepted for Review by the US FDA for Cholestatic Pruritus in Patients with Primary Biliary Cholangitis (PBC)

June 3, 2025

• Tenpoint Therapeutics Ltd. Announces FDA Acceptance of New Drug Application for Brimochol PF for the Treatment of Presbyopia

June 13, 2025

• KalVista Pharmaceuticals Announces FDA Will Not Meet PDUFA Goal Date for Sebetralstat NDA for Hereditary Angioedema Due to FDA Resource Constraints

June 17, 2025

• Aldeyra Therapeutics Resubmits Reproxalap New Drug Application for the Treatment of Dry Eye Disease

June 26, 2025

• Achieve Life Sciences Announces Submission of NDA to FDA for Cytisinicline as a Treatment of Nicotine Dependence for Smoking Cessation

June 30, 2025

• Unicycive Therapeutics Announces Receipt of Complete Response Letter for Oxylanthanum Carbonate for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis