FDA withdraws accelerated approval of infigratinib for metastatic cholangiocarcinoma with FGFR2

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FDA announced the final withdrawal of the approval of infigratinib (Truseltiq) for previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or other rearrangement. 

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The Pazdurs in their garden with their dog, Cleo. The dog’s full name is Cleopatra, Queen of Denial.In 1999, Rick Pazdur went in for a “perfunctory” final interview at FDA. Thinking it would only take a few minutes, his wife, Mary, decided to wait and have a quick cup of coffee at a nearby restaurant—Hooters.

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