FDA Approves Stelara for Pediatric Ulcerative Colitis

The US FDA approved Stelara (ustekinumab) for pediatric ulcerative colitis patients aged 2 and older, marking the first non-TNF alpha monoclonal antibody approved for pediatric inflammatory bowel disease. This decision is backed by adult ulcerative colitis data, pediatric Crohn's disease safety and pharmacokinetics, and positive phase 3 pediatric trial results.

This Wire brief sits within Fusion42's coverage of Biotech, and 2 sources have reported it between 31 Aug 2026 and 8 Sep 2026.