Amgen Inc. today announced submission of a Biologics License Application (BLA) with the U.S. FDA for denosumab, an investigational RANK Ligand inhibitor. The indications for which Amgen is seeking FDA approval are 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 details can be read here.
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