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Latest From Veru Inc.
Veru AdComm Highlights Differing EUA Philosophies Based On Lingering COVID-19 Deaths
In a close but negative panel vote on the company’s acute respiratory distress syndrome treatment VERU-111 (sabizabulin), majority of US FDA advisory committee says more study should come ahead of an emergency use authorization, not as an authorization condition.
FDA Is Still Lenient On COVID-19 EUAs, Veru’s Sabizabulin Advisory Panel Preview Docs Indicate
Agency poised to authorize Veru’s NME for COVID acute respiratory distress despite potential efficacy concerns and an unusually small safety database even by EUA standards. FDA assessment highlights continued burden of COVID despite political rhetoric downplaying current impact.
The Return Of The Advisory Committee: US FDA Has Busy Fall Ahead
The prototypical US FDA advisory committee review of a pending new drug application has become something of an endangered species. A suddenly busy October and November agenda suggests that might be changing.
‘The Pandemic Is Over’? Not For US FDA
President Biden’s informal declaration that the COVID-19 pandemic is ‘over’ likely portends a formal end of the Public Health Emergency. But many of the US FDA’s COVID flexibilities don’t directly depend on that decision.
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