Romvimza (vimseltinib) PDUFA Date (Deciphera Pharmaceuticals)

Name: FDA PDUFA Decision: Romvimza (vimseltinib)
Start: 2025-02-17

FDA PDUFA decision date for Romvimza (vimseltinib) is February 17, 2025. Developed by Deciphera Pharmaceuticals. Indication: Tenosynovial giant cell tumor (TGCT). Current status: Approved.

Indication

Tenosynovial giant cell tumor (TGCT)

Regulatory details

Company: Deciphera Pharmaceuticals
Therapeutic area: Oncology
Application type: NDA
Review type: Priority
PDUFA date: 2025-02-17
Outcome: Approved

Romvimza (vimseltinib) PDUFA Date — Deciphera Pharmaceuticals