Business · 11/05/2026Updated: 10/16/2026 · 1 min read

FDA Awards Priority Review Voucher to AVLAYAH Sponsor

Summary

The FDA has awarded a priority review voucher to Denali Therapeutics Inc. for its rare pediatric disease product AVLAYAH (tividenofusp alfa-eknm), approved on March 24, 2026.

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

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