Vivek Ramaswamy’s Enzyvant is hit with a CRL for manufacturing — delaying a new therapy for an ultra-rare killer
It was supposed to be Vivek Ramaswamy’s first drug approval, but the regenerative med company he set up to advance a new tissue-based approach to treating an ultra-rare condition in newborns has been hit with a complete response letter from the FDA.
The FDA rejected Enzyvant’s RVT-802, which set out to become the only therapy sanctioned to treat cases of pediatric congenital athymia — a condition marked by extreme immune deficiency.
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