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Otarmeni™ FDA Approval: World's First Gene Therapy for Genetic Hearing Loss (April 23, 2026)
On April 23, 2026, the FDA granted historic approval to Regeneron's Otarmeni™ — a single-dose gene therapy enabling 42% of OTOF-mutation children to perceive whispers at week 48 — the world's first gene therapy for genetic deafness. Crucial for Turkey: OTOF mutations account for 5% of national hearing loss diagnoses, and the drug is free in the U.S.
