Healio iconHealioAug 31, 2026

FDA expands Stelara use to children with ulcerative colitis

Stelara injection for the treatment of moderately to severely active ulcerative colitis in children aged 2 years and older, expanding the drug's use for both major forms of pediatric IBD. The decision follows the FDA's approval of Stelara (ustekinumab, Janssen) in April for children aged 2 years and older with Crohn's disease.

FDA expands Stelara use to children with ulcerative colitis

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Stelara injection for the treatment of moderately to severely active ulcerative colitis in children aged 2 years and older, expanding the drug's use for both major forms of pediatric IBD.

The decision follows the FDA's approval of Stelara (ustekinumab, Janssen) in April for children aged 2 years and older with Crohn's disease.

Ustekinumab is the first non-TNF-targeting monoclonal antibody to be approved for both pediatric CD and UC.

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Stelara injection for the treatment of moderately to severely active ulcerative colitis in children aged 2 years and older, expanding the drug's use for both major forms of pediatric IBD. The decision follows the FDA's approval of Stelara (ustekinumab, Janssen) in April for children aged 2 years and older with Crohn's disease. Ustekinumab is the first non-TNF-targeting monoclonal antibody to be approved for both pediatric CD and UC.

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