Did the FDA approve Stelara for pediatric ulcerative colitis in 2026?

Yes. On August 28, 2026, the FDA approved Stelara (ustekinumab) for moderately to severely active ulcerative colitis in pediatric patients ages 2 and older. The agency said this expands Stelara across both main pediatric inflammatory bowel diseases and makes it the first approved non-TNFα monoclonal antibody for these settings.