Posted by Michael Wonder on 01 Nov 2025
Johnson & Johnson submits application to US FDA for Stelara (ustekinumab) in the treatment of paediatric ulcerative colitis
31 October 2025 - Expanded Stelara indication seeks to treat children two years of age and older with moderately to severely active ulcerative colitis, based on week 52 data from UNIFI Jr.
Johnson & Johnson today announced the submission of a supplemental biologics license application to the US FDA seeking to expand approval of Stelara (ustekinumab) for the treatment of children two years and older with moderately to severely active ulcerative colitis.
