The U.S. Food and Drug Administration (FDA) has given the green light to a new, prefilled syringe presentation of GSK’s highly effective shingles vaccine, Shingrix.
An application from GSK to increase the use of its very effective RSV vaccine, Arexvy, has been formally approved by the U.S. Food and Drug [Read More…]
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 [Read More…]
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.
A significant step in Alzheimer’s care: The FDA’s updated approval for the Amyvid PET scan allows for better diagnosis and patient selection for the latest amyloid-based treatments
AstraZeneca’s Datroway has received US FDA approval for advanced EGFR-mutated lung cancer. This first-in-class TROP2-directed therapy offers a vital new option for patients who have exhausted previous treatments.
Novo Nordisk announced that its leading diabetes medication, Ozempic® (semaglutide), has received a positive recommendation in the EU for an updated label to include peripheral arterial disease.
The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) as the first and only targeted biologic treatment for adults with bullous pemphigoid, a rare and debilitating autoimmune skin disease.
Johnson & Johnson has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for the approval of STELARA® (ustekinumab) [Read More…]
