FDA Approves First-of-its-Kind Psoriasis and Arthritis Treatment for Children

JohnsonAndJohnson

The U.S. Food and Drug Administration (FDA) has given approval to TREMFYA® (guselkumab) for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in children. This groundbreaking approval makes TREMFYA® the first and only IL-23 inhibitor available for pediatric patients, offering a new ray of hope for thousands of children affected by these chronic conditions.

Roche Highlights New OCREVUS® Data Demonstrating Benefit in Diverse MS Populations and Presents Promising Long-Term Fenebrutinib Results at ECTRIMS 2025

Roche

Roche is set to present a wealth of new data at the 41st ECTRIMS Congress, highlighting the expanding benefits of its flagship multiple sclerosis therapy, OCREVUS® (ocrelizumab). New findings demonstrate a significant reduction in disability progression for adults with advanced primary progressive MS (PPMS) and reinforce its safety for pregnant women and their infants. The presentation will also include the first comparative data for OCREVUS in pediatric MS. Alongside these updates, Roche will showcase promising two-year results for its investigational oral BTK inhibitor, fenebrutinib, which showed near-complete suppression of disease activity in patients with relapsing MS ahead of pivotal Phase III readouts.

U.S. FDA Approves Johnson & Johnson’s TREMFYA® (guselkumab) Subcutaneous Induction for Adults with Ulcerative Colitis

JohnsonAndJohnson

Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved a new subcutaneous (at-home) induction option for TREMFYA® (guselkumab) for adults with moderately to severely active ulcerative colitis. This approval, based on the successful Phase 3 ASTRO trial, makes TREMFYA the first and only IL-23 inhibitor to offer a completely subcutaneous regimen for both induction and maintenance, providing a significant new convenience for patients managing their condition.

Lilly’s Oral GLP-1 Orforglipron Achieves Success in Third Phase 3 Trial, Triggering Global Regulatory Submissions

Eli Lilly and Company

Eli Lilly announced results from the Phase 3 ATTAIN-2 trial, where its oral GLP-1 receptor agonist orforglipron provided substantial weight loss and improved A1C for adults living with obesity and type 2 diabetes demonstrating efficacy and safety consistent with injectable medicines, and moving toward regulatory approval.