FDA issues priority review voucher for FAYUVI (rebisufligene etisparvovec-hopf)
The FDA announced that it has awarded a priority review voucher to the sponsor of FAYUVI, a gene therapy approved on September 17, 2026. The voucher is granted to Ultragenyx Pharmaceutical Inc. for this rare pediatric disease product that meets the criteria under the FD&C Act.
Primary source
Federal Register notice, October 6, 2026
Issuance of Priority Review Voucher; Rare Pediatric Disease Product; FAYUVI (rebisufligene etisparvovec-hopf)
Read the source: Issuance of Priority Review Voucher; Rare Pediatric Disease Product; FAYUVI (rebisufligene etisparvovec-hopf) federalregister.gov
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