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FDA rejection

This page shows the latest FDA rejection news and features for those working in and with pharma, biotech and healthcare.

New trial data for Keytruda in triple-negative breast cancer

New trial data for Keytruda in triple-negative breast cancer

triple-negative breast cancer (TNBC) following a recent US Food and Drug Administration (FDA) rejection in this indication. ... In March 2021, the US Food and Drug Administration (FDA) issued Merck &Co a complete response letter (CRL) rejecting a

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  • Pharma deals during February 2014 Pharma deals during February 2014

    This follows an FDA rejection due to its risk / benefit profile and demands for a further trial. ... According to Martin Shkreli, founder and CEO: “We also intend to move quickly to pursue FDA approval of Chenodal for CTX.".

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