Avastin Hearing: Genentech, CDER Dispute Relevance Of Second-Line Breast Cancer Data
The parties disagree on whether breast cancer studies conducted outside the first-line setting are relevant to CDER's proposed withdrawal of Avastin's accelerated approval for first-line use.
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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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To make your document look professionally produced, Word provides header, footer, cover page, and text box designs that complement each other. For example, you can add a matching cover page, header, and sidebar. Click Insert and then choose the elements you want from the different galleries.
