Category: Healthcare & Pharmaceuticals

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 News Oncology

GSK’s Blenrep Gets U.S. FDA Approval for Multiple Myeloma Treatment

GSK - GlaxoSmithKline

The FDA has approved GSK’s Blenrep (belantamab mafodotin) in combination with bortezomib and dexamethasone for adult patients with relapsed or refractory multiple myeloma. The decision, backed by the pivotal DREAMM-7 trial, introduces a new, accessible anti-BCMA treatment that significantly improved overall survival and progression-free survival compared to the standard of care. This milestone offers renewed hope for patients who have relapsed after at least two prior lines of therapy.

Regulatory Approval News

AstraZeneca’s Tezspire Gains EU Approval for Nasal Polyps, Offering New Hope for Patients

AstraZeneca

The European Commission has officially approved AstraZeneca’s Tezspire (tezepelumab) for adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP). This new add-on therapy offers hope for patients whose condition is uncontrolled by standard treatments, demonstrating efficacy in reducing polyp size, alleviating congestion, and decreasing the need for surgery.

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.

Clinical Trials News Weight-loss Drugs

Lilly’s Orforglipron, a New Oral Drug, Shows Promise for Type 2 Diabetes and Weight Loss in Late-Stage Trials

Eli Lilly and Company

Eli Lilly has announced positive late-stage trial results for orforglipron, its investigational once-daily oral GLP-1 drug. In Phase 3 studies, orforglipron demonstrated superior blood sugar control and significant weight loss in adults with type 2 diabetes, outperforming other existing medications. These results position it as a potential new standard of care and a convenient oral alternative to injectable treatments.

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.

Regulatory Approval News Oncology

FDA Approves Groundbreaking Combination Therapy for Extensive-Stage Small Cell Lung Cancer

Roche

In a major breakthrough for oncology, the U.S. FDA has approved a new combination therapy from Roche for a highly aggressive form of lung cancer. The treatment, which combines Tecentriq® (atezolizumab) and lurbinectedin (Zepzelca®), is the first of its kind for the maintenance treatment of extensive-stage small cell lung cancer (ES-SCLC). Clinical trial results show the regimen significantly reduces the risk of disease progression and death, offering new hope and a pivotal shift in how this challenging disease is managed post-chemotherapy.

Clinical Trials Biologics News Oncology

Amgen’s Repatha® (evolocumab) Succeeds in Landmark Phase 3 Trial, Showing Significant Reduction in Cardiovascular Events

amgen

Amgen announced that its landmark Phase 3 VESALIUS-CV clinical trial for Repatha® (evolocumab) met its primary endpoints, demonstrating a significant reduction in the risk of major adverse cardiovascular events (MACE) in high-risk individuals without a prior history of heart attack or stroke. The study, which enrolled over 12,000 patients, positions Repatha as the first and only PCSK9 inhibitor to show such a benefit in this primary prevention setting, offering a new hope for patients at high risk for cardiovascular disease.

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.