FDA Monthly Preview: Key April Decisions to Watch

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

1

The FDA is set to make several significant regulatory decisions in April 2026 across various medical specialties.
2

GTx-104 is under review for treating aneurysmal subarachnoid hemorrhage, with a target action date of April 23, 2026.
3

AXS-05 has been accepted for priority review for Alzheimer's disease agitation, with a target action date of April 30, 2026.
4

Sparsentan's review for focal segmental glomerulosclerosis has been extended, with a target action date of April 13, 2026.
5

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.

1