Johnson & Johnson has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking to expand the approval of STELARA® (ustekinumab) for use in children aged two years and older with moderately to severely active ulcerative colitis. This application is supported by data from the Phase 3 UNIFI Jr clinical trial and marks a step toward providing additional treatment options for pediatric patients with ulcerative colitis. Currently, STELARA® is approved for several indications in adults and children, but not for pediatric ulcerative colitis or Crohn's disease in the U.S. The review is ongoing, and no regulatory approval has been granted yet.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Johnson & Johnson published the original content used to generate this news brief on October 31, 2025, and is solely responsible for the information contained therein.