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FDA drug approval stories

Aug 28, 2026

FDA Approves Stelara for Pediatric Ulcerative Colitis

The FDA approved ustekinumab (Stelara) on August 28, 2026 for the treatment of moderately to severely active ulcerative colitis in pediatric patients aged 2 years and older, making it the first non-TNF biologic approved for pediatric IBD.

Aug 28, 2026·1 source
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Drug Approval and Clinical Trials

Related entities

StelaraPediatric careJanssen BiotechInflammatory bowel disease