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

FDA Monthly Preview: Key April Decisions to Watch

Several high-stakes FDA decisions across multiple specialties are expected this month.

  • By

  • Kathryn Wighton

  • March 31, 2026

  • 3 min

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    The FDA is set to make several significant regulatory decisions in April 2026 across various medical specialties.

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    GTx-104 is under review for treating aneurysmal subarachnoid hemorrhage, with a target action date of April 23, 2026.

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    AXS-05 has been accepted for priority review for Alzheimer's disease agitation, with a target action date of April 30, 2026.

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    Sparsentan's review for focal segmental glomerulosclerosis has been extended, with a target action date of April 13, 2026.

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    Teplizumab is being reviewed to expand its indication for children with stage 2 type 1 diabetes, with a target action date of April 29, 2026.

Original Source(s)

FDA Monthly Preview: Key April Decisions to Watch

  • by Kathryn Wighton

  • March 31, 2026

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