The FDA has accepted for priority review a new supplemental biologics license application for Winrevair to treat adults with ...

Merck’s recent acquisition announcement sends a strong signal regarding its urgency to tackle the impending Keytruda patent ...

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

Results from the Phase III ZENITH trial show that patients treated with Winrevair (sotatercept-csrk) for pulmonary arterial ...

The Saudi Food and Drug Authority (SFDA) has approved the registration of Winrevair (sotatercept) for the treatment of adult patients with World Health Organization (WHO) Functional Class II to III ...

WINREVAIR is currently approved in more than 45 countries based on the results from the STELLAR trial.

Merck has pulled off another acquisition which fits in its “sweet spot,” as described by CEO Rob Davis, paying $10 billion ...

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 ...

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 ...

Merck says it will acquire London-based Verona Pharma for about US$10bil, gaining a promising respiratory treatment as it ...

Phase 3 study results evaluating sotatercept-csrk in recently diagnosed adults with pulmonary arterial hypertension were announced.