J&J's TREMFYA wins FDA approval for subcutaneous ulcerative colitis treatment
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TREMFYA® (guselkumab) achieves U.S. approval for subcutaneous induction in adults with ulcerative colitis, now the first and only IL-23 inhibitor with a fully subcutaneous regimen
September 26, 2025 4:37 PM EDTTREMFYA® offers the flexibility of self-administration from the start of treatment, building on the prior approval of subcutaneous induction in Crohn's disease
TREMFYA® achieved significant rates of clinical remission and endoscopic improvement versus placebo at Week 12 with a subcutaneous induction regimen, consistent with IV induction
Johnson & Johnson is initiating a head-to-head study seeking to demonstrate the superiority of TREMFYA® vs. Skyrizi® (risankizumab) in Crohn's disease, based on the confidence in the clinical profile
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