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had earned a rare pediatric disease priority review voucher; agency says the notice was published in error and will be withdrawn.
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The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
User fee goal dates are coming up in October for more than 15 applications, according to the Pink Sheet’s US FDA Performance Tracker.