Ilaris Safety Data Inadequate For Gout Indication, FDA Panel Says
Arthritis Advisory Committee votes against approval of Novartis' biologic for treatment of gout attacks, citing the need for more data on long-term safety and retreatment, along with a narrower indication.
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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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