Category: Regulatory Approval

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.

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 Tendyne™ Device Receives FDA Approval for Minimally Invasive Mitral Valve Replacement

abbott

Abbott’s Tendyne™ 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.

Regulatory Approval Healthcare & Pharmaceuticals News

U.S. FDA Approves Roche’s Susvimo for Diabetic Retinopathy, Offering New Hope for Millions

Roche

Roche’s Susvimo® has received FDA approval for diabetic retinopathy, becoming the first continuous delivery treatment offering sustained vision benefits with just one refill every nine months. Backed by strong Phase III results, the implant provides a long-term solution for millions at risk of vision loss.