J&J Seeks U.S. FDA Approval to Expand STELARA® Use for Pediatric Ulcerative Colitis

JohnsonAndJohnson

Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the FDA for STELARA® (ustekinumab) to treat children aged two years and older with moderately to severely active ulcerative colitis. The filing is supported by data from the Phase 3 UNIFI Jr clinical trial, aiming to address the significant unmet needs for this pediatric patient population.

TREMFYA® (guselkumab) Demonstrates Durable Two-Year Remission in Crohn’s Disease, New Phase 3 Data Show

JohnsonAndJohnson

New 96-week data from the Phase 3 GALAXI and GRAVITI studies show high rates of sustained remission for TREMFYA® (guselkumab) in Crohn’s disease. At two years, over 86% of patients on maintenance doses achieved clinical remission, reinforcing its long-term efficacy as the only fully subcutaneous IL-23 inhibitor for the condition.

Johnson & Johnson Raises 2025 Sales Outlook on Strong Q3 Performance

JohnsonAndJohnson

Johnson & Johnson announced strong third-quarter 2025 financial results, with reported sales increasing by 6.8% to $24.0 billion. The company’s Innovative Medicine and MedTech divisions both contributed to this growth. As a result of this strong performance, Johnson & Johnson has raised its full-year 2025 sales guidance.

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.

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.

U.S. FDA Approves Johnson & Johnson’s INLEXZOâ„¢ (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 INLEXZOâ„¢ (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.