La Jolla Proceeds With Additional Riquent Dosing Study
High doses of lupus agent appear to be "well-tolerated" in healthy volunteers, firm says. Dose-response data are being collected in response to FDA's "approvable" letter. La Jolla plans to add the information to ongoing pivotal trial.
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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