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FDA Halts Elevidys Distribution After Boy's Death

7/28/2025

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Summary

Story summary

The FDA is probing the tragic death of an 8-year-old boy in Brazil, who passed away after receiving Sarepta Therapeutics' Elevidys gene therapy for Duchenne muscular dystrophy. In light of safety concerns, the FDA has called for a halt in Elevidys distribution. While Sarepta insists the treatment is not to blame, the investigation remains ongoing.

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Story summary

The FDA is probing the tragic death of an 8-year-old boy in Brazil, who passed away after receiving Sarepta Therapeutics' Elevidys gene therapy for Duchenne muscular dystrophy. In light of safety concerns, the FDA has called for a halt in Elevidys distribution. While Sarepta insists the treatment is not to blame, the investigation remains ongoing.