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Business · 11/04/2024Updated: 10/17/2026 · 1 min read

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

Summary

The FDA has issued a priority review voucher to Italfarmaco S.p.A., the manufacturer of DUVYZAT (givinostat), a rare pediatric disease product approved on March 21, 2024, under the Federal Food, Drug, and Cosmetic Act.

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

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