FDA Will Present Brilinta Panel With Alternative Explanation For Negative U.S. Data
FDA reviewers discredit AstraZeneca's suggestion that higher doses of aspirin explain ticagrelor's discordant results for U.S. versus overall trial participants - but also offer an alternative reason for the findings.
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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