Business · 06/05/2026Updated: 10/16/2026 · 1 min read
FDA Awards Priority Review Voucher to Regeneron for OTARMENI
Summary
The FDA is issuing a priority review voucher to Regeneron Pharmaceuticals, Inc. for its rare pediatric disease product OTARMENI (lunsotogene parvec-cwha), approved on April 23, 2026.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →