Advisory Committee Rejects Avandia Vs. Actos Comparison Data
FDA's advisory panel for the review of cardiovascular safety concerns with GlaxoSmithKline's Avandia refused to consider unvetted data on Takeda's competing thiazolidinedione Actos because the information has not yet been fully analyzed by FDA
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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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