Avid Amyvid Could Be Approved If Training Improves, Advisory Committee Says
The Peripheral and Central Nervous System Drugs Advisory Committee demands a second voting question to say the data support approval of the amyloid plaque diagnostic, but not until more consistent interpretation methods are developed.
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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