Alnylam: 3-Month Extension of Review Period for New Drug Application for Vutrisiran

 – New PDUFA goal date scheduled for July 14, 2022, due to amendment to address pending inspection classification at third-party secondary packaging and labeling facility –

– New facility has been identified and incorporated into existing regulatory submission which requires additional review time at FDA –

– No inspection observations were directly related to vutrisiran and no additional clinical data have been requested by FDA –

https://finance.yahoo.com/news/alnylam-announces-3-month-extension-113000217.html