FDA Establishes Regulatory Review Period for Acceleron's Winrevair, Opens Patent Extension Comment Period
July 07, 2025
July 07, 2025
WASHINGTON, July 7 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has determined the regulatory review period for Winrevair, a breakthrough therapy from Acceleron Pharma Inc. for adults with pulmonary arterial hypertension. This regulatory step is essential for Acceleron's application to extend several key patents covering Winrevair.
Winrevair is indicated to increase exercise capacity, improve the functional class and reduce the risk o . . .
Winrevair is indicated to increase exercise capacity, improve the functional class and reduce the risk o . . .