Merck’s MRK blockbuster PD-L1 inhibitor, Keytruda, approved for several types of cancer indications, is the company's biggest ...

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

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 ...

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

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] ...

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

WINREVAIR is the first activin signaling inhibitor therapy approved to treat PAH. WINREVAIR improves the balance between pro-proliferative and anti-proliferative signaling to modulate vascular ...

FDA Grants Priority Review for WINREVAIR™ (sotatercept-csrk) to Update Label Based on Results From ZENITH Trial. Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today ...

WINREVAIR may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use an effective method ...