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 April 2025

  • PDUFA Date: April 2, 2025
    • Reproxalap
    • Aldeyra Therapeutics, Inc.
    • Reproxalap is a first-in-class small-molecule modulator of reactive aldehyde species (RASP), is under review for the treatment of the signs and symptoms of dry eye disease.

  • PDUFA Date: April 3, 2025
    • Uplizna (inebilizumab-cdon)
    • Amgen
    • It is a humanized monoclonal antibody (mAb) for the treatment of adults with generalized myasthenia gravis (gMG).

  • PDUFA Date: April 18, 2025
    • Dupixent (dupilumab)
    • Sanofi & Regeneron
    • For the treatment of adults and pediatric patients aged 12 years and older with chronic spontaneous urticaria (CSU) whose disease is not adequately controlled with H1 antihistamine treatment.

  • PDUFA Date: April 21, 2025
    • Opdivo plus Yervoy (nivolumab plus ipilimumab)
    • Bristol Myers Squibb
    • For the first line for patients with unresectable hepatocellular carcinoma (HCC).

  • PDUFA Date: April 26, 2025
    • Pixclara (18F-floretyrosine or 18F-FET)
    • Telix Pharmaceuticals
    • It is a PET agent for the characterisation of progressive or recurrent glioma from treatment related changes in both adult and pediatric patients.

  • PDUFA Date: April 29, 2025
    • Elamipretide
    • Stealth BioTherapeutics Inc
    • A first-in-class mitochondria-targeted therapeutic, and the first FDA-approved therapy for Barth syndrome.

  • PDUFA Date: April 29, 2025
    • Prademagene zamikeracel (pz-cel)
    • Abeona Therapeutics
    • The treatment is an investigational gene therapy which has been developed for individuals with recessive dystrophic epidermolysis bullosa (RDEB).

  • PDUFA Date: April 30, 2025
    • Dihydroergotamine Nasal Powder
    • Satsuma Pharmaceuticals
    • It is an investigational dihydroergotamine (DHE) nasal powder product that is administered via a proprietary nasal delivery device for the acute treatment of migraine with or without aura.

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