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

Regulators squeezed in two final approvals before the calendar change with the UK approval of Merck’s Winrevair and the FDA’s ...

Shares of Merck & Co. Inc ($MRK) were in the spotlight this week after the pharmaceutical major secured regulatory approval ...

Last Friday, the Medicines and Healthcare Products Regulatory Agency approved Merck & Co Inc’s (NYSE:MRK) Winrevair ...

UK's Medicines and Healthcare products Regulatory Agency said on Tuesday it had approved Merck's therapy to treat a rare lung ...

Merck (NYSE:MRK) said a pivotal Phase 3 study for its drug Winrevair in the treatment of pulmonary arterial hypertension, or PAH, has met its primary endpoint. Topline results from the study ...

After the FDA approved both combination macitentan/tadalafil (Opsynvi) and the biologic therapy sotatercept (Winrevair) for ...

RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today positive topline results from the Phase 3 ZENITH study evaluating WINREVAIR ...

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Winrevair (sotatercept) to treat pulmonary ...

The Medicines and Healthcare products Regulatory Agency of the United Kingdom announced has approved the medicine sotatercept, Winrevair, to ...

MHRA approves Merck's Winrevair (sotatercept) for adults with PAH to enhance exercise capacity and reduce functional limitations. A 24-week study showed sotatercept improved 6-minute walking ...

Last Friday, the Medicines and Healthcare Products Regulatory Agency approved Merck & Co Inc’s (NYSE:MRK) Winrevair (sotatercept) for adult patients with pulmonary arterial hypertension (PAH).