The Priority Review

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Ultragenyx Pharmaceutical Inc.

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.