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 August 2024
  • AdCom Meeting Date: August 2, 2024
    • Arimoclomol
    • Zevra Denmark A/S
    • The Committee will discuss new drug application 214927, for arimoclomol, submitted by Zevra Denmark A/S, for the treatment of adults and pediatric patients 2 years of age and older with Niemann-Pick disease type C.
  • PDUFA Date: August 4, 2024
    • Afamitresgene Autoleucel
    • Adaptimmune Therapeutics
    • Afami-cel is an investigational engineered T-cell therapy for advanced synovial sarcoma.
  • PDUFA Date: August 11, 2024
    • Human Acellular Vessel (HAV)
    • Humacyte, Inc.
    • The Human Acellular Vessel (HAV) in urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated, and when autologous vein use is not feasible.
  • PDUFA Date: August 13, 2024
    • Lymphir
    • Citius Pharmaceuticals
    • An experimental treatment for the rare blood cancer relapsed or refractory cutaneous T-cell lymphoma after at least one prior systemic therapy.
  • PDUFA Date: August 14, 2024
    • Seladelpar
    • Gilead Sciences
    • An orally active peroxisome proliferator-activated receptor delta agonist for the treatment of primary biliary cholangitis (PBC).
  • PDUFA Date: August 14, 2024
    • Linvoseltamab
    • Regeneron Pharmaceuticals, Inc.
    • For the treatment of adult patients with relapsed/refractory (R/R) multiple myeloma (MM) that has progressed after at least three prior therapies.
  • PDUFA Date: August 20, 2024
    • Vorasidenib
    • Royalty Pharma
    • For the treatment of patients with IDH-mutant diffuse glioma.
  • PDUFA Date: August 28, 2024
    • Axatilimab
    • Incyte/Syndax Pharmaceuticals Inc
    • For the treatment of graft-vs-host-disease (GVHD) in patients who have failed at least 2 prior lines of systemic therapy.

Sign up for alerts and stay informed on the latest published guidelines, FDA decisions, and more!

Copyright © 2024 Guideline Central, All rights reserved.