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- FDA pushes back decision on Exelixis' zanzalintinib and Roche's Tecentriq combo for metastatic colorectal cancerThe FDA announced a delay in its decision on the approval of Exelixis' oral kinase inhibitor zanzalintinib when used with Roche's Tecentriq for metastatic colorectal cancer. The agency said it nee…
- FDA leadership stabilizes under new CBER and CDER heads and appoints first AI deputy commissionerAt the Food and Drug Administration, Karim Mikhail and Michael Davis have been confirmed as the permanent heads of the Center for Biologics Evaluation and Research and the Center for Drug Evaluatio…BioSpace · 2mo agoRegulatoryPositive