Doravirine/Islatravir PDUFA Date (Merck)
FDA PDUFA decision date for Doravirine/Islatravir is April 28, 2026. Developed by Merck. Indication: HIV-1 infection (once-daily oral combination). Current status: Approved.
Indication
HIV-1 infection (once-daily oral combination)
Notes
First NRTTI-based combo. Potential best-in-class oral HIV regimen.
Regulatory details
- Company: Merck
- Therapeutic area: Infectious Disease
- Application type: NDA
- Review type: Priority
- PDUFA date: 2026-04-28
- Outcome: Approved