Business · 23/02/2026Updated: 10/16/2026 · 1 min read
FDA Issues Priority Review Voucher for Rare Pediatric Disease Product WASKYRA (etuvetidigene autotemcel)
Summary
The FDA is issuing a priority review voucher to Fondazione Telethon ETS for its rare pediatric disease product WASKYRA (etuvetidigene autotemcel), approved on December 9, 2025, following a review of the Federal Food, Drug, and Cosmetic Act criteria.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →