The Priority Review

Tag

FAYUVI

1 story

  1. Regulation

    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.