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In the context of Guselkumab & Ulcerative colitis (UC), FDA approval covers guselkumab for the treatment of adults with moderately to severely active ulcerative colitis. Subsequent label expansions are for intravenous (IV) and subcutaneous (SC) induction/maintenance regimens (1)
The EMA/EC approval covers guselkumab for the treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response, loss of response, or intolerance to conventional therapy or a biologic treatment initially based on intravenous (IV) …