The Food and Drug Administration (FDA) protects public health by guaranteeing the safety, effectiveness, and security of pharmaceuticals and medical devices. The Prescription Drug User Fee Act (PDUFA) date marks the deadline by which the FDA must complete its review of drug applications. Occasionally, an advisory committee (AdCom) meeting is convened to assess the drug or device under consideration. Presented below is a comprehensive list of drugs and devices, along with the anticipated decision date.

Upcoming FDA Decisions for February 2025

  • AdCom Meeting Date: February 24, 2025
    • Meeting of the Cardiovascular and Renal Drugs Advisory Committee
    • The Committee will discuss supplemental new drug application (sNDA) 218276 S-004, for FABHALTA (iptacopan) oral capsules, submitted by Novartis Pharmaceuticals Corporation, for the treatment of adults with complement 3 glomerulopathy (C3G).

  • PDUFA Date: February 1, 2025
    • SPN-830
    • Supernus Pharmaceuticals, Inc.
    • SPN-830 is an investigational apomorphine infusion device for the continuous treatment of motor fluctuations (“off” episodes) in Parkinson’s disease (PD).

  • PDUFA Date: February 4, 2025
    • Zenocutuzumab 
    • Merus
    • Zenocutuzumab for the treatment of patients with NRG1-positive non–small cell lung cancer (NSCLC) and pancreatic cancer.

  • PDUFA Date: February 8, 2025
    • Brexpiprazole Plus Sertraline
    • Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S
    • Brexpiprazole in combination with sertraline is for the treatment of posttraumatic stress disorder (PTSD) in adults.

  • PDUFA Date: February 14, 2025
    • 5-in-1 Meningococcal ABCWY (MenABCWY) Vaccine
    • GSK
    • The MenABCWY combination vaccine will target the five groups of the bacteria Neisseria meningitidis (Men A, B, C, W and Y) that cause most invasive meningococcal disease (IMD) cases globally.

  • PDUFA Date: February 14, 2025
    • CHIKV VLP Vaccine
    • Bavarian Nordic A/S
    • CHIKV VLP, a vaccine candidate for immunization to prevent disease caused by chikungunya virus infection in individuals 12 years of age and older.

  • PDUFA Date: February 17, 2025
    • Vimseltinib
    • Deciphera Pharmaceuticals
    • Vimseltinib is an investigational, oral switch-control tyrosine kinase inhibitor specifically designed to selectively and potently inhibit CSF1R as a treatment for patients with tenosynovial giant cell tumor (TGCT).

  • PDUFA Date: February 28, 2025
    • Mirdametinib
    • SpringWorks Therapeutics
    • Mirdametinib is an investigational MEK inhibitor for the treatment of adult and pediatric patients with neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN).

  • PDUFA Date: February 28, 2025
    • ET-400 (Hydrocortisone Oral Solution)
    • Eton Pharmaceuticals, Inc
    • ET-400 is a proprietary room temperature stable formulation of oral hydrocortisone solution.

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