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Regeneron wins FDA approval for first gene therapy to restore hearing in deaf children, will offer for free

other · 2026-04-24

Regeneron Pharmaceuticals received FDA approval for the first gene therapy designed to restore hearing in children born with a rare genetic form of deafness. The one-time treatment targets a condition affecting about 50 babies annually in the United States. Regeneron announced it will provide the therapy free of charge. The approval marks a milestone in gene therapy for sensory disorders.

Key facts

  • Regeneron won FDA approval for the first gene therapy to restore hearing in deaf children
  • The therapy is a one-time treatment
  • It targets a rare genetic condition
  • About 50 babies are born each year in the U.S. with the condition
  • Regeneron will offer the therapy for free

Entities

Institutions

  • Regeneron Pharmaceuticals
  • FDA

Locations

  • United States

Sources