FDA approves STELARA for pediatric Crohn's disease from age two

The FDA approved STELARA (ustekinumab) for moderately to severely active Crohn's disease in patients aged two years and older, on April 15, 2026. The approval is based on the Phase 3 UNITI-Jr study, a 52-week trial with 8 weeks of induction and 44 weeks of maintenance. It adds a younger patient group to a drug that faces biosimilar erosion in the U.S.

• FDA approval date April 15, 2026; announced by J&J on May 1, 2026
• Indication: moderately to severely active Crohn's disease, patients aged two and older
• Basis: Phase 3 UNITI-Jr study, 52 weeks in total