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Old 04-26-2012, 11:03 PM   #1
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FDA issues Complete Response Letter to Amgen’s sBLA for XGEVA
Amgen today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the supplemental Biologics License Application (sBLA) for XGEVA (denosumab) to treat men with castration-resistant prostate cancer (CRPC) at high risk of developing bone metastases.

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