Amgen received a Complete Response Letter from the FDA for the BLA for Prolia (denosumab) in the treatment and prevention of postmenopausal osteoporosis. The letter requested several items, including further information on the design of Amgen’s previously submitted post-marketing surveillance program. The letter did not require additional pre-marketing clinical trials to complete the review of the treatment indication, but the FDA has requested a new clinical program to support approval...