ARTICLE | Clinical News

Romosozumab regulatory update

October 3, 2016 7:00 AM UTC

FDA accepted for review a BLA from Amgen for romosozumab to treat osteoporosis in postmenopausal women at increased risk of fracture. The PDUFA date is July 19, 2017. In February, the partners said romosozumab met the co-primary endpoints in the Phase III FRAME trial (see BioCentury, Feb. 29). ...