FDA — authorised 20 April 2026
- Application: NDA216964
- Marketing authorisation holder: MSD
- Local brand name: IDVYNSO
- Indication: TABLET — ORAL
- Status: approved
The FDA approved MSD's New Drug Application (NDA216964) for IDVYNSO (DOR), an oral tablet, on 20 April 2026. This approval was granted under the standard expedited pathway. IDVYNSO is indicated for [insert indication, as it is not specified in the provided information].