Business · 13/03/2025Updated: 10/17/2026 · 1 min read
FDA Awards Priority Review Voucher to Sponsor of Rare Pediatric Disease Product Gomekli
Summary
The FDA has awarded a priority review voucher to the sponsor of Gomekli (mirdametinib), a rare pediatric disease product approved on February 11, 2025, manufactured by SpringWorks Therapeutics, Inc.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →