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Puma Biotechnology Receives Day-180 List of Outstanding Issues from Committee for Medicinal Products for Human Use (CHMP)

LOS ANGELES–(BUSINESS WIRE)–Puma Biotechnology, Inc. (Nasdaq: PBYI) announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has issued its Day-180 List of Outstanding Issues in the process of their ongoing regulatory review of Puma’s Marketing Authorisation Application (MAA) for neratinib for the extended adjuvant treatment of HER2-positive early stage breast cancer in patients who have previously been treated with trastuzumab (Herceptin®)-based adjuvant therapy.
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