FDA Monthly Preview: Key May Decisions to Watch - Takeaways - MDSpire

FDA Monthly Preview: Key May Decisions to Watch

Several FDA decisions across multiple specialties are expected this month.

  • By

  • Kathryn Wighton

  • April 29, 2026

  • 4 min

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  • 1

    The FDA is set to make several key regulatory decisions in May 2026 across neurology, endocrinology, psychiatry, and ophthalmology.

  • 2

    VYVGART has received priority review for treating generalized myasthenia gravis, with a PDUFA date of May 10, 2026.

  • 3

    Afrezza's sBLA for pediatric diabetes treatment has been accepted, targeting a PDUFA date of May 29, 2026.

  • 4

    CTx-1301 for ADHD has an upcoming PDUFA date of May 31, 2026, following positive Phase 3 trial results.

  • 5

    ONS-5010/LYTENAVA is under FDA review after a Complete Response Letter, with feedback expected in May 2026.

Original Source(s)

FDA Monthly Preview: Key May Decisions to Watch

  • by Kathryn Wighton

  • April 29, 2026

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