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News 2026-09-22 10:52 UTC

MRK - U.S. FDA Approves Update to the Label for WINREVAIR™ (sotatercept-csrk) to Include Data from the Phase 3 HYPERION Trial Evaluating Adults Recently Diagnosed with Pulmonary Arterial Hypertension (PAH, WHO* Group 1 Pulmonary Hypertension)

MRK - U.S. FDA Approves Update to the Label for WINREVAIR™ (sotatercept-csrk) to Include Data from the Phase 3 HYPERION Trial Evaluating Adults Recently Diagnosed with Pulmonary Arterial Hypertension (PAH, WHO* Group 1 Pulmonary Hypertension)

News 2026-09-22 10:45 UTC

FDA approves updated WINREVAIR label for HYPERION trial data

Merck said the U.S. FDA approved an update to the U.S. label for WINREVAIR (sotatercept-csrk) for injection (45mg, 60mg) based on Phase 3 HYPERION trial data in adults recently diagnosed with pulmonary arterial hypertension (PAH, WHO Group 1).