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FDA approves first gene therapy for inherited deafness, shown to restore hearing for children with rare condition

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  • Drug name: Otarmeni (lunsotogene parvec-cwha) by Regeneron
  • Approved April 23, 2026
  • Treats OTOF gene mutation deafness (~50 US babies/year)
  • Trial of 20 kids: 16 had hearing improvements at 5 months
  • 5 of 12 followed for ≥11 months had hearing essentially restored to normal
  • Effect lasted…

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