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默克获得FDA同意扩大Winrevair标签
2025-10-27 21:15
- Merck (NYSE:MRK) has received approval from the U.S. FDA for an updated product label for Winrevair (sotatercept), available in 45mg and 60mg injections, aimed at treating adults with pulmonary arterial hypertension.
- This new approval broadens the use of Winrevair to include serious clinical events related to pulmonary arterial hypertension, such as hospitalizations, lung transplants, and fatalities.
- The label update is supported by findings from the phase 3 ZENITH trial, which evaluated the efficacy of Winrevair in patients with this condition.
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