Grifols Wins US FDA Approval for Rare Blood Disorder Drug Fesilty

MT Newswires · 2d ago
08:14 AM EST, 12/19/2025 (MT Newswires) -- Grifols (GRF.MC) said Friday it secured the US Food and Drug Administration's approval for Fesilty to treat acute bleeding episodes in children and adults with congenital fibrinogen deficiency, a rare genetic blood disorder. Developed by the Spanish healthcare group's majority-owned Biotest (BIO.F), Fesilty is slated for US launch by Grifols in the first half of 2026. The drug was approved in Germany under the brand name Prufibry in November 2025, with further regulatory authorizations in Europe expected in 2026.