Desmoid Tumor

• EMA approval · 2026-07-20
  EMA Authorised: Ogsiveo (nirogacestat hydrobromide) — Merck Europe B.V.

  Marketing authorization has been granted for Ogsiveo (nirogacestat hydrobromide) by EMA for desmoid tumors.

• FDA approval · 2026-03-10
  FDA Approved: OGSIVEO — Supplemental Application (SpringWorks Therapeutics, Inc.)

  The FDA approved a supplemental application for OGSIVEO (nirogacestat) from SpringWorks Therapeutics.

• 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.