source
- FDA issues final guidance on potency standards for cell and gene therapy developersThe U.S. Food and Drug Administration released a final guidance on Monday that sets out the expectations for sponsors of cell and gene therapies to demonstrate product potency. The document requir…
- FDA sets May 1 decision deadline for UniQure’s Huntington’s disease gene therapy after advisory committee meetingThe U.S. Food and Drug Administration announced that it has set a review date and scheduled an advisory committee meeting for UniQure’s gene therapy aimed at treating Huntington’s disease. The age…