Genentech Appeals To FDA's "Regulatory Flexibility"
The summary of the evidence Genentech will present at the June hearing on Avastin's breast cancer approval shows its case will focus on its proactive efforts to conduct a new confirmatory trial, but it also emphasizes the agency's options in applying its regulatory authority.
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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Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
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