ASTRAZENECA
Koselugo
Resolved
300days ago
Approval decision · Sep 10, 2025
What's at stake
A final FDA approval decision on Koselugo for its lead indication is expected Sep 10, 2025.
Primary source
· openFDA
verified 16h ago
“FDA approved Koselugo (NDA213756) — sponsor ASTRAZENECA; efficacy supplement (Efficacy); FDA action date 2025-09-10.”