Accelerated And Accompanied: Oncology Drugs Should Use Randomized Trials, FDA Panel Says
Single-arm studies for accelerated approval should be used only when the patient population is small or drug activity is high, the Oncology Drugs Advisory Committee says.
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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