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FDA adcom gears up for Puma, Emmaus votes

By Michael Fitzhugh
Staff Writer

Monday, May 22, 2017

FDA briefing documents framing a Wednesday ODAC review of Puma Biotechnology Inc.'s lead candidate, neratinib, highlight tolerability and trial amendment issues, but still appear supportive of the drug's efficacy as an extended adjuvant treatment for HER2-positive early stage breast cancer.

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