Category: Regulatory

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.

Regulatory Approval Healthcare & Pharmaceuticals News

U.S. FDA Approves AbbVie’s MAVYRET® to Treat Acute Hepatitis C in Adults and Children with 96% Cure Rate

AbbVie

In an important milestone for the treatment of hepatitis C, AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) approved a label expansion of MAVYRET® (glecaprevir/pibrentasvir), its pangenotypic, oral, direct-acting antiviral (DAA) therapy. The new indication [Read More…]

Medical Devices Healthcare & Pharmaceuticals News Regulatory Approval

Abbott’s Tendyneâ„¢ Device Receives FDA Approval for Minimally Invasive Mitral Valve Replacement

abbott

Abbott’s Tendyneâ„¢ device has secured FDA approval, revolutionizing mitral valve replacement. This minimally invasive system offers a crucial alternative for high-risk patients with severe mitral annular calcification, eliminating the need for open-heart surgery.