Provenge Panel's Uncertainty Was More Persuasive To FDA Than Its Vote
FDA found the uncertainty expressed by the advisory committee reviewing Dendreon’s Provenge to be a better guide for regulatory action than the panel’s numerical vote supporting approval, according to the FDA review documents for the first autologous cancer vaccine.
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.’
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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