Ulcerative Colitis

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.

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.

The first half of 2025 recap for gastroenterology spotlights GI FDA approvals, clinical trial data, and new guidance on bowel preparation for colonoscopy.

Subgroup analysis findings highlight duvakitug’s efficacy and tolerability across different levels of inflammation in ulcerative colitis.

Biomarker-informed molecular guidance led to greater achievement of disease control compared with standard “best care” for IBD anti-TNF therapy.

Our Q1 recap for gastroenterology spotlights regulatory updates, clinical trial data, and new research and guidance about colorectal cancer screening.

The March 2025 month in review spotlights an RX Review about USMSTF guidance on bowel prep for colonoscopy, an FDA approval, and clinical trial updates.

Examining recent developments in ASUC management, including predictive markers for colectomy, new treatment approaches, and ongoing challenges.

Topline results from the phase 2b ANTHEM-UC study show all 3 doses of once-daily oral icotrokinra met the primary endpoint for clinical response.

The gastroenterology month in review spotlights GI FDA news, research about colorectal cancer and alcohol complications, and new data for mirikizumab.

Amneal Pharmaceuticals launched mesalamine 800 mg delayed-release tablets for UC and received FDA approval for various lenalidomide doses for blood cancers.

Future intensified intra-class competition among Omvoh, Skyrizi and Tremfya is expected as each brand attempts differentiation.

The sBLA seeks to expand golimumab’s approval for UC to include pediatric patients ≥ 2 years of age and is supported by data from the PURSUIT program.

Positive phase 2b data show duvakitug met primary endpoints for clinical remission in ulcerative colitis and endoscopic response in Crohn disease.

This month in review spotlights GI pipeline updates and news from the 2024 NASPGHAN and ACG annual meetings.

Post hoc analyses from the LIBERTY trials support infliximab as either a monotherapy or combination therapy for ulcerative colitis or Crohn's disease.

The decision is based on rates of clinical and endoscopic remission with guselkumab in the ongoing phase 2b/3 QUASAR study.

The July 2024 gastroenterology month in review highlights FDA news, GI pipeline updates, and a new clinical practice update from the American Gastroenterological Assocation.

Data from INSPIRE and COMMAND were used to support risankizumab’s FDA approval for ulcerative colitis, demonstrating the IL-23 inhibitor’s impact on clinical remission.

The June 2024 gastroenterology month in review highlights FDA news and other pipeline developments in GI as well as the publication of the latest installment of Qazi Corner.