FDA Extends Review of Gene Therapy for Rare Immune Disorder
February 14th 2024Rocket’s application for Kresladi is being extended by three months for regulators to review additional information submitted at the request of the FDA. The new Prescription Drug User Fee Act (PDUFA) date is now June 30, 2024.
FDA Assigns Action Date for Arexvy to Prevent RSV in 50 to 59 Population
February 6th 2024The Prescription Drug User Fee Act date is June 7, 2024, for the additional indication of preventing respiratory syncytial virus (RSV) in adults aged 50 to 59 who are at increased risk. It is already approved for those over the age of 60.