This decision is based on the randomised MITIGATE trial data, which showed the antibody's potential to reduce disease activity by minimising flares in individuals, upholding its established safety The post FDA grants breakthrough therapy status for Amgen's Uplizna to treat IgG4-RD appeared first on Pharmaceutical Business review.
Amgen is a California-based multinational biopharmaceutical company that develops human therapeutics for the treatment of diseases including cancer and cardiovascular.