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Latest From CytoDyn, Inc.
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.
Troubled leronlimab is placed on partial clinical hold in HIV, full clinical hold in COVID-19. While searching for a new CEO, CytoDyn tries to reassure investors about its business plan going forward.
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.
Keeping Track: Spectrum Submits Poziotinib; US FDA Approves Daré’s Xaciato, Expands Heron Zynrelef Label
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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