Ulcerative Colitis

Abivax’s ABTECT Part 2 showed Week 44 responses and safety consistency with obefazimod in refractory UC patients.

Tulisokibart became the first anti-TL1A therapy to achieve clinical remission in a phase 3 ulcerative colitis trial.

Study 108 interim data show 68% of UC patients remained in clinical remission at week 144 after de-escalating from 50 mg to 25 mg obefazimod daily.

If approved, the novel corticosteroid therapy would be the first and only FDA-approved hydrocortisone acetate suppository.

Positive 12-week induction data from Part A of the phase 2 trial highlight the potential best-in-class safety and efficacy of SPY001, a novel anti-α4β7 therapy.

The Q4 recap for gastroenterology spotlights GI FDA news, new AGA guidelines, trial data for UC therapies, and more.

The gastroenterology year in review covers FDA approvals, IBD breakthroughs, IL-23 therapies, new guidelines, and advances in GI care.

Study findings highlight the prevalence of steroid use in IBD care and identify key subgroups at higher risk of exposure.

This FDA News Month in Review provides a round-up of regulatory decisions from November 2025.

FDA approves Omvoh (mirikizumab-mrkz) for monthly maintenance of ulcerative colitis, simplifying treatment for patients with this chronic condition.

The decision updates the indication statements for ulcerative colitis and Crohn’s disease to allow use in patients who have received ≥ 1 approved systemic therapy.

An audio recap of the top 5 stories in healthcare news from the week of 10/5-10/11.

LUCENT-3 open-label extension study data establish mirikizumab-mrkz (Omvoh) as the first and only IL-23p19 to show sustained long-term outcomes in UC through 4 years.

Rubin reflects on the FDA approval of a SC induction regimen for guselkumab (Tremfya) in UC and explains the significance of having both IV and SC induction options in IBD.

Positive topline results showed obefazimod met its primary endpoint for clinical remission at week 8 in the 50 mg dose cohort in ABECT-1 and ABECT-2.