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

Company Name	Merck & Co Inc. MRK
Drug Name	Winrevair (sBLA)
Event Name	FDA decision to update the label of Winrevair update to labeling for WINREVAIR to include the results of the Phase 3 ZENITH trial
Event Date	10/25/2025
Outcome Date	10/27/2025
Outcome	FDA expanded the indication of WINREVAIR to include components of the clinical worsening events: hospitalization for PAH, lung transplantation and death, based on phase 3 ZENITH study, on Oct.27, 2025
Drug Status	Priority review
Rival Drugs
Market Potential
Other Approvals	The FDA approved Winrevair for the treatment of adults with pulmonary arterial hypertension on March 26, 2024
News

Return to FDA Calendar

Slide Shows