Genentech Bid To Gain Full Approval For Avastin On Amassed PFS Data Gets July ODAC Hearing
Roche division also seeks approval for bevacizumab in new combinations based on AVADO and RIBBON-1 trial results, but the question remains whether the progression-free survival endpoint used in all the trials is sufficient for full approval.
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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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