• Amgen, UCB resubmit biologic license application for romosozumab

    3 monthes ago - By Healio

    Amgen and UCB have resubmitted a biologics license application to the FDA for romosozumab for the treatment of osteoporosis in postmenopausal women at high risk for fracture, according to a press release from both companies.
    In July 2017, the FDA issued a complete response letter for the biologics license application for romosozumab , asking Amgen to add safety and efficacy data from the ARCH and BRIDGE studies into the drug application. The original application, submitted to the FDA in September 2016, was based on efficacy and safety data from the phase 3 placebo-controlled Fracture
    Read more ...