No Appeal: Eloxatin Decision Gives District Courts Primacy On 30-Month Stays
Brand companies have fewer tools to fight off generic challenges following a ruling that prevents them from reinstating a 30-month stay on FDA approvals if they initially lose the patent case in district court
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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