BioCentury
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). ...