New Drug Applications Archive for 2025
January 2, 2025
January 7, 2025
January 16, 2025
January 17, 2025
January 23, 2025
January 28, 2025
January 29, 2025
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
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
February 19, 2025
February 26, 2025
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
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
March 31, 2025
New drug applications archive
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
- 2011
- 2010
- 2009
- 2008
- 2007
- 2006
- 2005
- 2004
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.