BioCentury
ARTICLE | Clinical News

FDA accepts sBLA for Amgen's Xgeva to prevent fractures in MM patients

June 22, 2017 12:26 PM UTC

Amgen Inc. (NASDAQ:AMGN) said FDA accepted an sBLA for Xgeva denosumab (Prolia, Pralia, Ranmark, AMG 162) to include prevention of fractures and other skeletal-related events (SREs) in patients with bone metastases from multiple myeloma (MM). The PDUFA date is February 3, 2018...