Alyglo (human immune globulin IV 10%) / GC Biopharma - LARVOL DELTA

U.S. FDA Accepts Biologics License Application for GC Biopharma’s GC5107B (Immune Globulin Intravenous (Human), 10% Liquid) (PRNewswire) - "GC Biopharma...announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's resubmission of the Biologics License Application (BLA) for its GC5107B (Immune Globulin Intravenous (Human) for patients with primary humoral immunodeficiency (PI). The Prescription Drug User Fee Act (PDUFA) target action date is January 13, 2024. If approved, GC Biopharma would be able to provide more treatment options for patients with PI in the U.S."

BLA • PDUFA date • Immunology • Primary Immunodeficiency