Tag: Johnson&Johnson

Regulatory Approval Healthcare & Pharmaceuticals News Oncology

U.S. FDA Approves AKEEGA®, the First Precision Therapy for BRCA2-Mutated Metastatic Prostate Cancer, Slashing Disease Progression Risk by 54%

JohnsonAndJohnson

A major advance in prostate cancer treatment: The FDA has approved AKEEGA® for BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC). This first-of-its-kind precision therapy, combining niraparib and abiraterone, demonstrated a significant 54% reduction in the risk of disease progression or death compared to the standard of care. This milestone offers a personalized, highly effective option for patients with this aggressive genetic mutation.

Regulatory Approval Autoimmune Diseases Healthcare & Pharmaceuticals News

Johnson & Johnson’s Imaavy Wins European Commission Approval for Generalized Myasthenia Gravis

JohnsonAndJohnson

Johnson & Johnson has secured European Commission approval for Imaavy (nipocalimab), a novel treatment for generalized myasthenia gravis (gMG). This authorization marks the first FcRn blocker approved in Europe for a broad population that includes both adults and adolescents (aged 12+), offering a new option for sustained disease control.

Clinical Trials Autoimmune Diseases Healthcare & Pharmaceuticals News

New 48-Week Data Shows TREMFYA® (guselkumab) Substantially Inhibits Joint Damage in Psoriatic Arthritis

JohnsonAndJohnson

New long-term data from the Phase 3b APEX study confirms that TREMFYA® (guselkumab) is the only IL-23 inhibitor proven to substantially inhibit the progression of structural joint damage in patients with active psoriatic arthritis, with results sustained through 48 weeks.

Regulatory Autoimmune Diseases News

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.

Clinical Trials Autoimmune Diseases News

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.

Business Healthcare & Pharmaceuticals News

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.

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.