Kedrion Biopharma Announces the Extension of a U.S. Agreement with Grifols to Support Long-Term and Continued Access to GAMMAKED®
The agreement maintains key therapies within Kedrion’s U.S. immunodeficiency and auto immune disorders portfolio while reinforcing broad, reliable access for people living with serious and chronic immune-mediated disorders FORT LEE, N.J., August 18, 2026 – Kedrion Biopharma, a global biopharmaceutical company specializing in therapies for rare and serious diseases, today announced an extension to their relationship with Grifols under which Kedrion sells GAMMAKED® [Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified], an intravenous immunoglobulin (IVIG) therapy, in the United States to support patients living with serious and chronic conditions. The agreement
Kedrion Biopharma Advances Rare Disease Scientific Evidence Generation at ISTH 2026
Kedrion Biopharma brought new scientific insights, expert-led discussions, and rare disease evidence generation to the 34th International Society on Thrombosis and Haemostasis (ISTH) Congress in Paris, contributing to ongoing efforts to improve outcomes for patients. “Scientific leadership is an essential part of how we deliver for patients,” said Bob Rossilli, Chief Commercial Officer, Kedrion Biopharma.
Kedrion Biopharma and InstaLILY Convene Industry Leaders to Advance the Future of AI in Healthcare at NY Tech Week
Advancing practical, responsible AI innovation in highly regulated industries New York — June 1, 2026 — Kedrion Biopharma and InstaLILY are hosting the Rare Connections: Healthcare AI Innovation Summit on June 3 as part of NY Tech Week. The invitation-only, half-day forum will bring together thought leaders across pharma, technology, investment, and research to explore
Kedrion Launches QIVIGY® in the U.S. with Nationwide Distribution
Kedrion has activated a robust nationwide U.S. distribution network to support the commercial availability of QIVIGY, its FDA approved 10% Intravenous Immunoglobulin (IVIG) therapy. Kedrion’s distribution model is designed to provide broad access across specialty pharmacies, infusion centers, hospitals, and other sites of care nationwide, ensuring consistent supply and scalable reach as demand for IVIG
Kedrion Biopharma and CuraScript SD Team Up to Launch YIMMUGO in the U.S.
When Kedrion Biopharma was presented with the opportunity to commercialize YIMMUGO in the United States, the company moved swiftly. The decision reflected a clear commitment to expanding access to immunoglobulin therapies and supporting patients with timely, reliable treatment options. Once the marketing strategy was in place, attention turned to distribution—a critical piece of the launch
FDA grants Orphan Drug Designation to investigational plasma-derived treatment for Congenital Aceruloplasminemia
The US Food and Drug Administration (FDA) has granted Orphan Drug Designation to our investigational plasma-derived treatment for Congenital Aceruloplasminemia, a rare genetic disorder affecting iron metabolism. This designation marks a significant milestone in our commitment to addressing the unmet medical needs of patients living with ultra-rare diseases and exemplifies sustainable innovation in plasma-derived therapies.
Kedrion Biopharma Receives Orphan Drug Designation for COAGADEX® for Acquired Factor X Deficiency (aFXD) and Starts Clinical Trial to Evaluate Efficacy and Safety
FORT LEE, N.J., July 29, 2025 /PRNewswire/ — Kedrion Biopharma is proud to announce that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Coagulation Factor X human (tradename COAGADEX) for the treatment of acquired Factor X Deficiency (aFXD), a rare hematologic disorder with a global prevalence of < 1 in 1,000,000