CytoDyn’s Promotion Of Investigational Drug Leronlimab Once Again Rebuked By US FDA
OPDP warning letter objects to video interview in which CytoDyn's then CEO touts use of the investigational drug for COVID-19. The exec says he is ‘making up numbers’ but if the pattern continues there will be ‘the most fantastic results’ anybody could ever imagine.
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Keeping Track: Gilead Gets CRL For Bulevirtide, CytoDyn Withdraws Leronlimab; Eye and CNS Drug Submissions
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Althera’s misleading claims about its cholesterol drug Roszet is based on a ‘scientifically unsound analysis,’ OPDP tells company. FDA says studies cited in the pamphlet for doctors do not support claims regarding the magnitude of treatment effect.
Bausch gets an untitled letter from the US FDA criticizing a video and webpage promoting its psoriasis lotion. The agency also objects to superiority efficacy claims based on post hoc analyses of a single phase II trial after expressing similar concerns to the company two years ago.