“Exceptional” Approval Could Replace “Accelerated” For Rare Cancer Drugs
An "exceptional" approval process should be carved out of the accelerated approval program for products targeting rare cancers where there is little likelihood of completing confirmatory trials, members of FDA's Oncologic Drugs Advisory Committee recommended
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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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