Merck & Co Inc., MRK, FDA Calendar, PDUFA Date

Company Name	Merck & Co Inc. MRK
Drug Name	Winrevair (sBLA)
Event Name	FDA decision on WINREVAIR seeking approval to update the U.S. product label in pulmonary arterial hypertension to include Phase 3 HYPERION trial results
Event Date	09/21/2026
Outcome Date
Outcome	pending
Drug Status
Rival Drugs
Market Potential
Other Approvals	In 2024, WINREVAIR was approved for the treatment of adults with pulmonary arterial hypertension (PAH, Group 1 PH) to increase exercise capacity, improve WHO* functional class (FC), and reduce the risk of clinical worsening events
News

Return to FDA Calendar

Slide Shows