GC Biopharma scores FDA nod for immunoglobulin therapy Alygl

South Korea’s GC Biopharma Corp. has gained U.S. FDA approval for its immune-deficiency plasma drug, Alyglo (immune globulin intravenous, human-stwk; IVIG-SN 10%), five months after refiling its BLA, five months after refiling its BLA and before its PDUFA date of Jan. 13, 2024.

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