29 September 2025 - Kedrion Biopharma announced today that it has received FDA approval for Qivigy immune globulin intravenous (human)-kthm 10% liquid, indicated for treatment of adults with primary humoral immunodeficiency—a serious and often underdiagnosed group of disorders that compromise the immune system's ability to function effectively.
Qivigy's efficacy and safety were evaluated in a 12 month clinical study in adults with primary humoral immunodeficiency.