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Reiterating 2024 Financial Guidance: Total Revenue of $915-985 Million, Representing YOY Growth of 10-19%, Adjusted EBITDA of $535-585 Million, Representing...
Takeda TSE4502NYSETAK today announced that the U.S. Food and Drug Administration FDA has approved GAMMAGARD LIQUID Immune Globulin Infusion Human 10 solution as an intravenous immunoglobulin IVIG therapy to improve neuromuscular disability and impairment in adults with chronic inflammatory demyelinating polyneuropathy CIDP.
New Indication Delivers on Takeda’s Commitment to Expanding its Broad and Diverse Immunoglobulin Portfolio to Meet the Needs of People Living with CIDP Approval Supported by Phase 3...
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.
This marks the first oral monotherapy approved for the rare blood disorder.