Category: News

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.

Healthcare & Pharmaceuticals Business News

GSK Acquires Efimosfermin, Bolstering Liver Disease Pipeline with Potential Best-in-Class Treatment

GSK - GlaxoSmithKline

GSK has finalized its acquisition of efimosfermin, a promising new therapeutic for steatotic liver disease. The deal, valued at up to $2 billion, positions GSK to potentially launch a best-in-class treatment for MASH and ALD by 2029, significantly enhancing its hepatology portfolio.

Regulatory Approval Healthcare & Pharmaceuticals News

AstraZeneca’s Imfinzi Gains EU Approval as First Perioperative Immunotherapy for High-Risk Bladder Cancer

AstraZeneca

The European Commission has approved AstraZeneca’s Imfinzi, establishing a new standard of care for muscle-invasive bladder cancer. This landmark decision makes Imfinzi the first perioperative immunotherapy available to patients in the EU, following a pivotal Phase III trial where the regimen significantly reduced the risk of cancer recurrence and death. This approval marks a transformative moment for patients with this high-risk disease.

Weight-loss Drugs Clinical Trials Healthcare & Pharmaceuticals News

Amgen’s MariTide Shows Promising Results in Phase 2 Obesity Study with Monthly Dosing

amgen

Amgen presented Phase 2 data showing that its investigational obesity therapy, maritide, administered monthly, led to significant weight loss in adults with obesity or overweight. The treatment was generally well tolerated, supporting further clinical development.