Biotest AG Announces FDA Approval of Grifols' Fesilty™

Biotest AG, a member of the Grifols group, revealed the FDA approval for Fesilty™ (fibrinogen, human-chmt). This product, developed and manufactured by Biotest, will soon enter the U.S. market through Grifols, targeting the first half of 2026.

Designed for treating acute bleeding in patients with congenital fibrinogen deficiency, Fesilty™ represents a significant step in expanding healthcare access. CEO Dr. Jörg Schüttrumpf remarked on the importance of this FDA approval in broadening therapeutic options worldwide.

Production occurs at Biotest's state-of-the-art facility in Germany, boasting high efficiency and robust viral safety. As part of the Grifols group, Biotest advances plasma-derived therapies, enhancing patient access globally.