Gloucester's Istodax Gains FDA Approval Ahead Of New Regulatory Requirements
With FDA's approval a week ahead of the PDUFA date, Gloucester Pharmaceuticals will bring its first product to market, the second HDAC inhibitor approved in cancer.
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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