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Home » April 26 PDUFA Date Set for Amgen’s Denosumab
April 26 PDUFA Date Set for Amgen’s Denosumab
August 26, 2011
Amgen’s denosumab has received an April 26, 2012, Prescription Drug User Fee Act (PDUFA) action goal date from the FDA for its sBLA to reduce the risk of bone metastases in men with castrate-resistant prostate cancer (CRPC).