FDA Awards Priority Review Voucher to Leadiant Bioscience for Rare Pediatric Disease Product REVCOVI

Summary

The US Food and Drug Administration (FDA) has issued a priority review voucher to Leadiant Bioscience Inc. for its rare pediatric disease product REVCOVI, following a review of the product's eligibility under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Food and Drug Administration Safety and Innovation Act (FDASIA).