6 Gastroenterology Headlines You Missed in May 2026

May was a busy month in gastroenterology, marked by regulatory approvals, practice-changing data presentations at Digestive Disease Week (DDW) 2026, and continued advances in the management of inflammatory bowel disease (IBD) and eosinophilic esophagitis (EoE). From expanded treatment options for pediatric patients to promising new therapies for difficult-to-treat manifestations of Crohn’s disease (CD) and ulcerative colitis (UC), the month highlighted the rapid pace of innovation across the specialty.

Among the notable regulatory developments were approvals from the US Food and Drug Administration (FDA) for single-dose vials of famotidine injection and an expanded pediatric indication for linaclotide (Linzess), making the therapy available to children as young as 2 years of age with functional constipation. Meanwhile, data presented at DDW showcased progress in IBD, including positive phase 2b results for the investigational co-antibody JNJ-4804 in refractory UC and CD, as well as encouraging phase 3 findings supporting guselkumab for perianal fistulizing CD.

Additional research presented during the month provided new insights into treatment optimization and long-term outcomes. Investigators reported improvements in esophageal distensibility among patients with EoE treated with dupilumab and shared real-world evidence suggesting favorable long-term treatment persistence with risankizumab in CD.

Here’s a look at 6 key gastroenterology headlines from May 2026 you may have missed:

FDA Approves Famotidine Injection USP Single-Dose Vials

On May 13, 2026, the FDA approved Lupin Pharmaceuticals’ Abbreviated New Drug Applications for Famotidine Injection USP, 20 mg/2 mL (10 mg/mL), Single-Dose Vials, bioequivalent to the reference listed drug (RLD), Pepcid Injection, 10 mg/mL of Merck Sharp & Dohme Corp. Famotidine is a histamine-2 (H2) receptor antagonist that reduces gastric acid secretion and is used to treat gastrointestinal conditions associated with excess acid production.

FDA Approves Linaclotide (Linzess) for Functional Constipation in Patients 2 Years And Older

On May 27, 2026, the FDA approved Ironwood Pharmaceuticals’ linaclotide (Linzess) for pediatric patients ≥ 2 years of age with functional constipation (FC), expanding its previous approval for patients ≥ 6 years of age with FC.With this decision, linaclotide is now available for children ages 2-5 years with FC and remains the only FDA-approved prescription therapy for pediatric FC.

JNJ-4804 Phase 2b Data Show Higher Week-48 Remission in Refractory UC, Crohn Disease

Johnson & Johnson announced phase 2b results for the investigational co-antibody JNJ-4804 in adults with moderately to severely active UC or CD who had inadequate response or intolerance to systemic therapies, including a heavily pretreated subgroup with failure of ≥ 2 systemic therapy classes.

Data from the DUET-CD and DUET-UC studies were presented at DDW 2026 in Chicago, IL, and showed the fixed-dose combination outperformed golimumab and was numerically higher than guselkumab on several week-48 efficacy measures in the overall study populations, with larger relative differences described in the highly refractory subgroup.

Related: DUET-UC Data Highlight Potential of Dual-Pathway Targeting in Refractory Ulcerative Colitis

REMODEL: Dupilumab Improves Esophageal Distensibility in EoE at 24 Weeks

Results from the randomized, double-blind phase of the phase 4 REMODEL trial indicate that dupilumab significantly improved esophageal distensibility in adults with active eosinophilic esophagitis (EoE) compared with placebo at 24 weeks. The findings, which were presented at DDW 2026 in Chicago, IL, by Evan Dellon, MD, a professor of medicine and adjunct professor of epidemiology at the University of North Carolina School of Medicine in Chapel Hill, suggest that the IL-4/IL-13 pathway inhibitor not only addresses mucosal inflammation in EoE but also produces measurable improvements in a functional marker of fibrostenotic disease, a dimension of EoE pathology that has historically lacked dedicated therapeutic evidence.

Related: Dupilumab Improves Esophageal Distensibility in EoE, With Evan Dellon, MD, MPH

Guselkumab Shows Efficacy in Perianal Fistulizing Crohn's Disease in Phase 3 FUZION Trial

Guselkumab (Tremfya) demonstrated significantly increased rates of combined fistula remission compared with placebo at week 24 in the phase 3 FUZION trial, marking what investigators describe as the first randomized controlled trial of an approved IBD therapy to show efficacy in perianal fistulizing Crohn's disease in 2 decades. The data from Johnson & Johnson were presented as late-breaking findings at DDW 2026.

Related: Phase 3 FUZION Data Support Guselkumab in Perianal Fistulizing Crohn’s Disease

Real-World Data Favor Risankizumab for Long-Term Persistence in Crohn's Disease

With a growing roster of advanced therapies available for CD, treatment sequencing has become one of the most consequential decisions a gastroenterologist makes. While clinical trial data inform efficacy and safety, they do not capture what happens over the years a patient spends on a given drug in the real world. A claims-based analysis presented at DDW 2026 in Chicago, IL, offers a different lens, taking a closer look at real-world switch rates. Gil Melmed, MD, a gastroenterologist at Cedars-Sinai, presented data from the US-payer claims database analysis examining real-world switching rates over 24 months among patients with CD initiating risankizumab, adalimumab, infliximab, ustekinumab, or vedolizumab.