Amgen has submitted a Biologics License Application (BLA) with the FDA for denosumab, an investigational RANK Ligand inhibitor. Amgen is seeking approval for treatment and prevention of postmenopausal osteoporosis (PMO) in women, and treatment and prevention of bone loss in patients undergoing hormone ablation for either prostate or breast cancer. The BLA contains data from six Phase III trials involving more than 11,000 patients, according to Amgen. “Two Phase III pivotal studies with ...