When the US Food and Drug Administration announced a priority review voucher award for Enzyvant Therapeutics, Inc.’s pediatric congenital athymia treatment, there was just one problem – the tissue-based, regenerative therapy has not been approved.
Premature PRV: US FDA Mistakenly Announces Voucher Award For Enzyvant Ahead Of Approval
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had earned a rare pediatric disease priority review voucher; agency says the notice was published in error and will be withdrawn.
