May 8th 2024
If approved, midomafetamine would be the first psychedelic-assisted therapy approved for any mental health condition. The advisory committee meeting is June 4, 2024.
FDA Sets Date for Full Approval, Broader Indication for Elevidys
February 16th 2024The FDA has set a PDUFA date of June 21, 2024, to convert the accelerated approval to full approval and expand the labeling of the gene therapy Elevidys beyond the current use in children aged 4 and 5 with Duchenne muscular dystrophy.
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.