The US Food and Drug Administration's current approach to biosimilar labeling lacks transparency and requires changes to align with the agency's own Transparency Initiative, a joint citizen petition from two biopharmaceutical trade groups suggests1.
The US Food and Drug Administration's current approach to biosimilar labeling lacks transparency and requires changes to align with the agency's own Transparency Initiative, a joint citizen petition from two biopharmaceutical trade groups suggests1.
The Biotechnology Industry Organization (BIO) and the Pharmaceutical Research and Manufacturers of America (PhRMA) petitioned the FDA to include in...
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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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