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Premature PRV: US FDA Mistakenly Announces Voucher Award For Enzyvant Ahead Of Approval

Executive Summary

Congenital athymia treatment Rethymic (RVT-802) is still under FDA review, with an 8 October user fee goal date, but FDA announced the regenerative medicine product had earned a rare pediatric disease priority review voucher; agency says the notice was published in error and will be withdrawn.

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