Tag: Ulcerative Colitis

Regulatory Approval Autoimmune Diseases News Regulatory

U.S. FDA Approves Lilly’s Omvoh (mirikizumab-mrkz) as a Single-Injection Monthly Maintenance Dose for Ulcerative Colitis

Eli Lilly and Company

Eli Lilly has received FDA approval for a new single-injection maintenance dose of Omvoh (mirikizumab-mrkz) for adults with moderately to severely active ulcerative colitis. This approval simplifies the treatment regimen from two monthly injections down to just one, offering the same proven efficacy in a more convenient format. The new 200 mg/2 mL prefilled pens and syringes are expected to be available in the U.S. in early 2026.

Regulatory Approval Autoimmune Diseases News

U.S. FDA Approves Johnson & Johnson’s SIMPONI® (golimumab) for Pediatric Ulcerative Colitis

JohnsonAndJohnson

Johnson & Johnson announces that the U.S. FDA has approved SIMPONI® (golimumab) for the treatment of moderately to severely active ulcerative colitis in children weighing at least 15 kg. This approval provides a new subcutaneous treatment option for younger UC patients.

Clinical Trials Autoimmune Diseases News

Lilly’s Omvoh Shows Sustained, Long-Term Efficacy in Ulcerative Colitis and Crohn’s Disease

Eli Lilly and Company

Eli Lilly and Company announced a significant milestone for Omvoh (mirikizumab-mrkz), which is now the first and only IL-23p19 antagonist to demonstrate four years of sustained, corticosteroid-free comprehensive patient outcomes for individuals living with ulcerative colitis (UC).