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Business · 24/06/2019Updated: 10/17/2026 · 1 min read

FDA Awards Priority Review Voucher to Sponsor of Rare Pediatric Disease Product ZOLGENSMA

Summary

The FDA has issued a priority review voucher to AveXis, Inc., the manufacturer of ZOLGENSMA, a rare pediatric disease product, following a review of the product's eligibility under the FD&C Act and FDASIA.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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