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Evaluating Dose Intensification Strategies for Ustekinumab in Crohn’s Disease: Insights from the REScUE Trial
Gastroenterologyclinical trialCrohn’s disease

Evaluating Dose Intensification Strategies for Ustekinumab in Crohn’s Disease: Insights from the REScUE Trial

By MedXY|Jul 13, 2026

The REScUE study compared two ustekinumab dosing intensification regimens after secondary loss of response in Crohn’s disease, finding no superiority of more frequent dosing regarding steroid-free remission at 48 weeks.

The Dawn of the “No-Clinical-Trial” Era for Biosimilars: FDA’s Historic Ustekinumab Approval Shift
Clinical UpdatesbiosimilarsFDA

The Dawn of the “No-Clinical-Trial” Era for Biosimilars: FDA’s Historic Ustekinumab Approval Shift

By MedXY|Oct 6, 2025

The US FDA’s unprecedented exemption of clinical efficacy studies for a ustekinumab biosimilar marks a transformative regulatory milestone, reshaping biosimilar development, market dynamics, and patient access worldwide.

Early Control of Ulcerative Colitis and Its Impact on Long-Term Outcomes: Insights from the UNIFI Phase 3 Study
Clinical Updateslong-term outcomesulcerative colitis

Early Control of Ulcerative Colitis and Its Impact on Long-Term Outcomes: Insights from the UNIFI Phase 3 Study

By MedXY|Oct 5, 2025

Achieving disease clearance early after induction therapy with ustekinumab in ulcerative colitis patients predicts sustained clinical remission, symptom control, and improved quality of life over four years.

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