Biotechnology

Clinical Trials

Regulatory Approval

Market Analysis

Pfizer and Astellas report groundbreaking Phase 3 EMBARK trial results showing XTANDI® (enzalutamide) plus leuprolide significantly improves overall survival in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC) and high-risk biochemical recurrence. This marks the first time an androgen receptor inhibitor-based therapy has shown a definitive survival benefit in this specific patient population, offering new hope for extending lives through early and effective treatment.

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.

Novo Nordisk has applied to the European Medicines Agency (EMA) for a new, increased dosage of Wegovy® (semaglutide), a well-known medication for weight loss, of 7.2 mg. Given that clinical trial data indicates a substantially higher reduction in weight than the currently available doses, this move intends to provide individuals […]

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.