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Wednesday, March 25, 2026

Denali wins FDA accelerated approval for AVLAYAH in pediatric Hunter syndrome

 

Denali wins FDA accelerated approval for AVLAYAH in pediatric Hunter syndrome neurologic symptoms, receives Rare Pediatric Disease Priority Review Voucher

  • AVLAYAH (tividenofusp alfa-eknm) approved for treatment of neurologic manifestations of Hunter syndrome in pediatric patients.
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