Desmoid-type Fibromatosis

• EMA approval · 2026-03-31
  EMA Authorised: Ogsiveo (nirogacestat hydrobromide) — SpringWorks Therapeutics Ireland Limited

  EMA authorised Ogsiveo (nirogacestat hydrobromide) for desmoid tumors, designated as an orphan medicine in the EU.

• FDA approval · 2024-04-04
  FDA Approved: OGSIVEO — Supplemental Application (SpringWorks Therapeutics, Inc.)

  The FDA approved a supplemental application for OGSIVEO (nirogacestat) from SpringWorks Therapeutics, expanding the drug's approved use.

• FDA approval · 2023-11-27
  FDA Approved: OGSIVEO — Original Application (SpringWorks Therapeutics, Inc.)

  FDA approved OGSIVEO (nirogacestat) through an original NDA submitted by SpringWorks Therapeutics, Inc. for the treatment of desmoid tumors.