ARTICLE | Company News
FDA reviewing romosozumab BLA
September 26, 2016 7:00 AM UTC
Amgen Inc. (NASDAQ:AMGN) and partner UCB Group (Euronext:UCB) said FDA accepted a BLA for romosozumab ( AMG 785) to treat osteoporosis in postmenopausal women at increased risk of fracture. Its PDUFA date is July 19, 2017.
In February, the partners said romosozumab met the co-primary endpoints of a Phase III study (see BioCentury Extra, Feb. 22). ...