Will REMS Delay Generics? Revlimid Petition May Help Determine The Answer
Dr. Reddy’s asks FDA to spell out policy to assure that new Risk Evaluation and Mitigation Strategies will be used to block generics. Celgene’s refusal to make Revlimid available for bioequivalence study is at issue.
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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