FDA Approves Multaq With REMS, Without Mortality Claim
FDA approves Sanofi-Aventis’ atrial fibrillation drug Multaq with a Risk Evaluation and Mitigation Strategy to ensure the drug is used only in patients whose hearts have returned to normal rhythm.
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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