Avastin Breast Cancer Approval Memo Comes Back To Haunt FDA’s Pazdur
Reflected in the regulatory struggle over Avastin’s (bevacizumab) metastatic breast cancer claim is the uncertainty underlying drug approval decisions for FDA and sponsors, laying bare the sometimes tenuous evidence with which the agency has to work.
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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