Sue Sutter explains how the US Food and Drug Administration's handling of issues around protein content differences, statistical analyses of quality data and immunogenicity testing for Sandoz's Zarxio may prove instructive for future 351(k) applicants.
Sue Sutter explains how the US Food and Drug Administration's handling of issues around protein content differences, statistical analyses of quality data and immunogenicity testing for Sandoz's Zarxio may prove instructive for future 351(k) applicants.
From the outsider's perspective, the US Food and Drug Administration’s review and approval of Sandoz's biosimilar, Zarxio (filgrastim-sndz), may have...
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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.’
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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