Dordaviprone PDUFA Date (Jazz Pharmaceuticals)

Name: FDA PDUFA Decision: Dordaviprone
Start: 2025-08-18

FDA PDUFA decision date for Dordaviprone is August 18, 2025. Developed by Jazz Pharmaceuticals. Indication: H3 K27M-mutant diffuse glioma. Current status: Approved.

Indication

H3 K27M-mutant diffuse glioma

Regulatory details

Company: Jazz Pharmaceuticals
Therapeutic area: Oncology / CNS
Application type: NDA
Review type: Priority
PDUFA date: 2025-08-18
Outcome: Approved

Dordaviprone PDUFA Date — Jazz Pharmaceuticals