Merck (MRK) stock in focus as its lung disease drug Winrevair gains FDA priority review for a label update based on Phase 3 ...

Merck eyes growth beyond Keytruda with PAH drug Winrevair, aiming to offset the looming loss of exclusivity in 2028.

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

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

WINREVAIR is FDA-approved for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1) to increase exercise capacity, improve WHO functional class (FC) and reduce the risk ...

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

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

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

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

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