Tag: FDA Approval

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

Roche’s Gazyva/Gazyvaro Gets U.S. FDA Approval for Lupus Nephritis Treatment

Roche

Roche announced today that the U.S. Food and Drug Administration (FDA) has approved Gazyva/Gazyvaro (obinutuzumab) for the treatment of adult patients with active lupus nephritis. Based on positive results from Phase II and III clinical trials, this new therapy offers a significant advancement for those suffering from this severe kidney complication of lupus, showing superiority over standard therapy alone.

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.

Regulatory Approval Autoimmune Diseases News

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.

Oncology News Regulatory Approval

FDA Approves Lilly’s Inluriyo (imlunestrant) for Advanced ER+, HER2- Breast Cancer with ESR1 Mutation

Eli Lilly and Company

The U.S. Food and Drug Administration (FDA) has officially approved Eli Lilly and Company’s Inluriyo (imlunestrant), a new oral therapy for adult patients with advanced or metastatic estrogen receptor-positive (ER+), HER2-negative breast cancer that has an ESR1 mutation. The approval is based on the pivotal Phase 3 EMBER-3 trial, which demonstrated that Inluriyo significantly reduced the risk of disease progression or death by 38% in this patient population, offering a new and convenient treatment option for a challenging form of breast cancer.

Regulatory Approval Healthcare & Pharmaceuticals News

U.S. FDA Approves Johnson & Johnson’s INLEXZO™ (gemcitabine intravesical system), a Groundbreaking Bladder-Sparing Treatment for a High-Risk Form of Bladder Cancer

JohnsonAndJohnson

U.S. Food and Drug Administration (FDA) has officially approved INLEXZO™ (gemcitabine intravesical system), a novel drug-delivery system from Johnson & Johnson set to revolutionize care for adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). This first-of-its-kind therapy offers a significant bladder-sparing alternative for a high-risk patient group often facing complete bladder removal. Clinical trials showed an 82% complete response rate, marking a major advancement in bladder cancer treatment.

Regulatory Approval News

FDA Approves Updated Label for Lilly’s Alzheimer’s Drug Kisunla (donanemab-azbt), Offering a Safer Dosing Schedule

Eli Lilly and Company

The U.S. Food and Drug Administration (FDA) has officially approved an updated label for Eli Lilly’s groundbreaking Alzheimer’s drug, Kisunla (donanemab-azbt). This significant update introduces a new, more gradual dosing schedule specifically designed to enhance patient safety by reducing the risk of amyloid-related imaging abnormalities (ARIA), a critical side effect.