Business · 16/09/2020Updated: 10/17/2026 · 1 min read
FDA Awards Priority Review Voucher to AstraZeneca for Rare Pediatric Disease Product
Summary
The FDA has issued a priority review voucher to AstraZeneca for its rare pediatric disease product KOSELUGO (selumetinib, AZD6244), 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 →