Exelixis Announces Three-Month FDA Review Period Extension For Its Zanzalintinib New Drug Application In Combination With Atezolizumab For The Treatment Of Metastatic Colorectal Cancer
In response to an FDA information request, Exelixis had submitted updated safety and efficacy data, which the FDA has deemed a major amendment. The updated Prescription Drug User Fee Act action date is March 3, 2027.
Exelixis sent the FDA extra safety information about a cancer medicine, so the FDA needs three more months to review it. When companies get asked for more data, it usually means the FDA is being careful before saying yes.
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