Posted by Michael Wonder on 31 Jul 2023
US FDA accepts biologics license application for GC Biopharma's GC5107B (immune globulin intravenous (human), 10% liquid)
31 July 2023 - GC Biopharma today announced that the US FDA has accepted the Company's resubmission of the biologics license application for its GC5107B (immune globulin intravenous (human) for patients with primary humoral immunodeficiency.
The PDUFA target action date is 13 January 2024.
