Merck (NYSE:MRK) announced Wednesday that the U.S. Food and Drug Administration (FDA) granted priority review for its request ...

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug ...

ZENITH was the first of its kind in PAH to focus purely on hard outcomes like death, transplant, or long-term hospitalization ...

Rahway, New Jersey Thursday, July 3, 2025, 09:00 Hrs [IST] ...

Welcome to Fierce Pharma's regulatory tracker for the second half of 2025. | In this tracker, Fierce Pharma is recording the ...

Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% ...

Merck's Winrevair gains FDA priority review for PAH label update after ZENITH trial shows major reduction in serious events and strong clinical impact.

US pharma giant Merck & Co today revealed that the US Food and Drug Administration (FDA) has accepted and granted priority ...

Merck MRK announced that the phase III HYPERION study evaluating its pulmonary arterial hypertension (“PAH”) drug, Winrevair ...

Merck's Winrevair reduced clinical worsening in PAH patients in the Phase 3 HYPERION trial, building on prior positive study ...

About WINREVAIR™ (sotatercept-csrk) for injection, for subcutaneous use, 45 mg, 60 mg. WINREVAIR is FDA-approved for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group ...

Compared to the placebo, Winrevair lowered the risk of all-cause death, lung transplantation, and PAH-related hospitalization by 76% (HR=0.24; p<0.0001). Only 17.4% of patients in the Winrevair arm ...