Newsroom

October 31, 2025

Johnson & Johnson submits application to U.S. FDA for STELARA® (ustekinumab) in the treatment of pediatric ulcerative colitis

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

Innovative Medicine

October 27, 2025

TREMFYA® (guselkumab), the first and only IL-23 inhibitor with a fully subcutaneous treatment regimen, demonstrates durable remission in Crohn’s disease at two years

Clinical remission rates were over 85% for both TREMFYA® maintenance doses at 96 weeks in both the Phase 3 GRAVITI and GALAXI studies TREMFYA® is the only IL-23 inhibitor to demonstrate durable endoscopic and clinical remission with a fully subcutaneous regimen in moderately to severely active Crohn’s disease

Innovative Medicine

October 27, 2025

Icotrokinra maintains standout combination of therapeutic benefit and a favorable safety profile in once-daily pill through 28 weeks in ulcerative colitis

Building on 12-week findings, icotrokinra demonstrated clinically meaningful outcomes at Week 28 with 31.7% of patients achieving clinical remission and 38.1% showing endoscopic improvement versus placebo in the Phase 2b ANTHEM-UC study Results support Phase 3 clinical development of icotrokinra, a first-in-class targeted oral peptide that precisely blocks the IL-23 receptor, in both moderately to severely active ulcerative colitis and Crohn’s disease

Innovative Medicine

October 7, 2025

U.S. FDA approves SIMPONI® (golimumab) for the treatment of pediatric ulcerative colitis

Approval expands SIMPONI® indication to treat children weighing at least 15 kg with moderately to severely active ulcerative colitis SIMPONI® is the only approved treatment to offer a monthly maintenance dose for this patient population

Innovative Medicine

October 7, 2025

TREMFYA® (guselkumab) is first and only IL-23 inhibitor to demonstrate sustained clinical and endoscopic outcomes with a fully subcutaneous regimen through 48 weeks in ulcerative colitis

Patients treated with subcutaneous TREMFYA® achieved clinically meaningful results in both clinical remission (36.7%) and endoscopic remission (25.9%) at Week 48 in the Phase 3 ASTRO study Clinical and endoscopic outcomes were demonstrated across both biologic-naïve and biologic-refractory sub-groups TREMFYA® is the only IL-23 inhibitor with a fully subcutaneous regimen, following recent FDA approval of SC induction in adults with ulcerative colitis

Innovative Medicine

October 7, 2025

Icotrokinra data in ulcerative colitis show potential for a standout combination of therapeutic benefit and a favorable safety profile in once-daily pill

Icotrokinra met the primary endpoint of clinical response at all three doses, with 36.5% of patients treated with the highest dose achieving endoscopic improvement at Week 12 in the Phase 2b ANTHEM-UC study These data support the promise of a first-in-class targeted oral peptide that selectively blocks the IL-23 receptor as a potential new option for people with moderately to severely active ulcerative colitis

Newsroom

Press releases

Johnson & Johnson submits application to U.S. FDA for STELARA® (ustekinumab) in the treatment of pediatric ulcerative colitis

TREMFYA® (guselkumab), the first and only IL-23 inhibitor with a fully subcutaneous treatment regimen, demonstrates durable remission in Crohn’s disease at two years

Icotrokinra maintains standout combination of therapeutic benefit and a favorable safety profile in once-daily pill through 28 weeks in ulcerative colitis

U.S. FDA approves SIMPONI® (golimumab) for the treatment of pediatric ulcerative colitis

TREMFYA® (guselkumab) is first and only IL-23 inhibitor to demonstrate sustained clinical and endoscopic outcomes with a fully subcutaneous regimen through 48 weeks in ulcerative colitis

Icotrokinra data in ulcerative colitis show potential for a standout combination of therapeutic benefit and a favorable safety profile in once-daily pill

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Newsroom

Press releases

Johnson & Johnson submits application to U.S. FDA for STELARA® (ustekinumab) in the treatment of pediatric ulcerative colitis

TREMFYA® (guselkumab), the first and only IL-23 inhibitor with a fully subcutaneous treatment regimen, demonstrates durable remission in Crohn’s disease at two years

Icotrokinra maintains standout combination of therapeutic benefit and a favorable safety profile in once-daily pill through 28 weeks in ulcerative colitis

U.S. FDA approves SIMPONI® (golimumab) for the treatment of pediatric ulcerative colitis

TREMFYA® (guselkumab) is first and only IL-23 inhibitor to demonstrate sustained clinical and endoscopic outcomes with a fully subcutaneous regimen through 48 weeks in ulcerative colitis

Icotrokinra data in ulcerative colitis show potential for a standout combination of therapeutic benefit and a favorable safety profile in once-daily pill

You are now leaving jnj.com/innovativemedicine