Amgen (Nasdaq: AMGN) announced top-line results from a Phase 3 trial evaluating XGEVA(TM) (denosumab) versus placebo in 1,432 men with castrate-resistant prostate cancer. The trial, known as the '147 study, demonstrated that XGEVA significantly improved median bone metastasis-free survival by...
Amgen Inc. (NASDAQ: AMGN) announced that the U.S. Food and Drug Administration (FDA) has approved XGEVA™ (denosumab), the first and only RANK Ligand inhibitor for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors. XGEVA was approved following a 6...
Amgen Inc. (Nasdaq: AMGN) announced that the U.S. Food and Drug Administration (FDA) has approved Prolia™ (denosumab) for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or...
Amgen Inc. (Nasdaq: AMGN) announced that the U.S. Food and Drug Administration (FDA) has evaluated the content of the Company's Complete Response submission for Prolia(TM) (denosumab) in the treatment of postmenopausal osteoporosis and classified it as a Class 2 resubmission. With the Class 2...
Amgen Inc. (Nasdaq: AMGN) announced that the U.S. Food and Drug Administration (FDA) has evaluated the content of the Company's Complete Response submission for Prolia(TM) (denosumab) in the treatment of postmenopausal osteoporosis and classified it as a Class 2 resubmission. With the Class 2...