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 ...

Merck's Winrevair (sotatercept) gains UK approval for PAH treatment. Key trial results highlight significant exercise ...

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

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

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 ...

Publication on Dec. 12, 2024, of data analysis regarding Merck & Co. Inc.’s Winrevair (sotatercept) in Clinical Pharmacology & Therapeutics may have put investors in mind of the odds for the activin ...

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 ...

Merck Sharp & Dohme’s sotatercept gets UK MHRA marketing approval to treat adult patients with pulmonary arterial hypertension: United Kingdom Friday, January 3, 2025, 17:00 Hrs ...

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).