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Grifols Secures FDA Approval for FESILTY Fibrinogen Concentrate for Congenital Fibrinogen Deficiency

Grifols SA has received FDA approval for its FESILTY fibrinogen concentrate to treat congenital fibrinogen deficiency. Developed by Biotest, the product will be available in the US by mid-2026, expanding Grifols' bleeding management therapies portfolio. The original content was published by Grifols SA on December 19, 2025.

Reuters·
US
GRFS
+1.12%
Reuters·
US
GRFS
+1.12%

Biotest Wins German Approval for Prufibry Human Fibrinogen Therapy

Biotest AG has received approval from the Paul-Ehrlich-Institut in Germany for its human fibrinogen therapy, Prufibry® (BT524). This therapy is aimed at patients with fibrinogen deficiency, providing a reliable solution for preventing and controlling severe bleeding, especially during surgeries and trauma. The product's approval is supported by clinical studies confirming its efficacy and safety. The market launch in Germany is anticipated by the end of 2025, with plans for further approvals in other European and international markets.

Reuters·
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Reuters·
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12:13 ET YIMMUGO® Now Available in the U.S.: Kedrion Biopharma Commercializes a New Ig Therapy for PI

Kedrion Biopharma has announced the U.S. launch of YIMMUGO (Immune Globulin Intravenous, Human-dira, 10%), a new therapy for primary immunodeficiency (PI). Approved by the FDA on June 13, 2024, YIMMUGO is a highly purified 10% IVIG indicated for patients aged 2 and older. This product, developed by Biotest AG, aims to address the growing demand for treatment options in the PI market, which affects approximately 500,000 people in the U.S. YIMMUGO is available through a limited distribution network, with CuraScript SD as its exclusive commercial partner.

prnewswire·
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prnewswire·
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Biotest AG Concluded Annual General Meeting

Biotest AG held its Annual General Meeting on July 2, 2025, where shareholders approved a €0.04 dividend per preference share for 2024. The actions of the Executive Board and Supervisory Board for the 2024 financial year were also approved, along with all other agenda items by a large majority. This news was generated by Public Technologies and is for informational purposes only.

Reuters·
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Reuters·
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Biotest AG Names New CEO

Biotest AG said Wednesday a new chief executive officer took the helm as of the same day. New CEO Jörg Schüttrumpf joins the German biotechnology company from its main shareholder Grifols . Outgoing CEO Peter Janssen was dismissed "with immediate effect by mutual agreement."

Trading View·
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Trading View·
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