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

Upcoming FDA Decisions for May 2025

  • AdCom Meeting Date: May 5, 2025
    • Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee Meeting
    • The Committees will discuss the findings of the completed ER/LA OA PMRs 3033-1 and 3033-2. These PMRs are prospective (3033-1) and retrospective (3033-2) epidemiologic studies that examined the serious risks and predictors of misuse, abuse, addiction, and fatal and non-fatal opioid overdose in patients with long-term use of opioid analgesics for management of chronic pain, including patients prescribed ER/LA OAs.

  • PDUFA Date: May 7, 2025
    • Nucala (mepolizumab)
    • GSK
    • A new indication for the use of Nucala (mepolizumab), an interleukin-5 (IL-5) antagonist monoclonal antibody, as an add-on maintenance treatment for chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype.

  • PDUFA Date: May 22, 2025
    • Zoryve (roflumilast) foam 0.3%
    • Arcutis Biotherapeutics
    • For the treatment of adults and adolescents 12 years and older with scalp and body psoriasis.

  • PDUFA Date: May 24, 2025 (final approval)
    • Yutrepia (Treprostinil Injection)
    • Liquidia Technologies, Inc.
    • An inhaled dry powder formulation of treprostinil tentatively approved for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.

  • PDUFA Date: May 26, 2025
    • Welireg® (belzutifan)
    • Merck
    • An oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor for the treatment of adult and pediatric patients (12 years and older) with advanced, unresectable, or metastatic pheochromocytoma and paraganglioma (PPGL).

  • PDUFA Date: May 28, 2025
    • ET-400 (hydrocortisone)
    • Eton Pharmaceuticals
    • A proprietary, room temperature stable, oral solution formulation of the approved glucocorticoid hydrocortisone in development for use in children.

  • PDUFA Date: May 28, 2025
    • mRNA-1283
    • Moderna
    • mRNA-1283 is a next-generation COVID-19 vaccine candidate.

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