osteoporosis

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Japan approves Amgen's osteoporosis drug

Amgen’s osteoporosis bone-forming drug Evenity (romosozumab) has been approved in Japan, ahead of a crunch review by advisers to the US regulator later this month.

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Amgen and UCB re-file Evenity for US approval

Amgen and UCB have resubmitted their application for US approval of Evenity as an osteoporosis treatment, hoping that the additional data they have provided will help overcome the FDA’s pre

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FDA rejects Amgen/UCB osteoporosis drug

The FDA has rejected Amgen and UCB’s Evenity (romosozumab) osteoporosis drug after a late-stage trial unexpectedly highlighted a potential cardiac safety risk.