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 October 2024
  • AdCom Meeting Date: October 10, 2024
    • Vaccines and Related Biological Products
    • The committee will discuss and make recommendations on the strain selection for the influenza virus vaccines for the 2025 southern hemisphere influenza season. The committee will discuss pandemic preparedness for highly pathogenic avian influenza virus including considerations for vaccine composition for (H5) vaccines.

  • AdCom Meeting Date: October 10, 2024
    • Elamipretide hydrochloride injection
    • Stealth BioTherapeutics Inc.
    • The Committee will discuss the new drug application (NDA) 215244 for the treatment of Barth Syndrome.

  • PDUFA Date: October 8, 2024
    • Dasiglucagon
    • Zealand Pharma
    • For the prevention and treatment of congenital hyperinsulinism (CHI).

  • PDUFA Date: October 8, 2024
    • Neoadjuvant nivolumab with chemotherapy followed by surgery and adjuvant nivolumab
    • Bristol Myers Squibb
    • For the perioperative treatment of resectable stage IIA to IIIB non-small cell lung cancer (NSCLC).

  • PDUFA Date: October 21, 2024
    • Oclaiz (CAM2029)
    • Camurus
    • An investigational, ready-to-use octreotide for subcutaneous administration under development for the treatment of acromegaly, as well as gastroentero-pancreatic neuroendocrine tumors (GEP-NET), and polycystic liver disease (PLD).

  • PDUFA Date: October 25, 2024
    • Sulopenem etzadroxil/probenecid
    • Iterum Therapeutics
    • For the treatment of urinary tract infections (UTI) linked to susceptible bacteria in women aged 18 years and older.

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