Amgen's Denosumab: Quick Takes from FDA's Advisory Committee Meeting

FDA’s Reproductive Health Products Advisory Committee meeting on Amgen’s osteoporosis drug could have derailed denosumab’s prospects at a number of key turning points. But Amgen’s presentation combined with the drug’s effi cacy profi le pushed the investigational product through a key regulatory toll gate relatively unscathed.

Ramsey Baghdadi

FDA's advisory committee meeting reviewing the marketability of Amgen Inc.'s osteoporosis drug denosumab (Prolia) was one of the most important...

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