An Avastin Loophole: Hamburg Could Decide To Retain Approval During Confirmatory Trial
Even if the commissioner determines the grounds for withdrawing Avastin's accelerated approval in breast cancer have been met, she could decide to retain the claim while Genentech conducts additional confirmatory trials, the hearing notice explains.
Learn what's happening at the US FDA. On the go.
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Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
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