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BRIEF-FDA accepts supplemental biologics license application for Prolia
October 9, 2017 / 8:08 PM / 2 months ago

BRIEF-FDA accepts supplemental biologics license application for Prolia

Oct 9 (Reuters) - Amgen Inc

* FDA accepts supplemental biologics license application for Prolia® (denosumab) in glucocorticoid-induced osteoporosis

* Amgen Inc - ‍FDA has set a prescription drug user fee act (PDUFA) action date of May 28, 2018​

* Amgen Inc - ‍adverse events and serious adverse events were similar between treatment groups and consistent with known safety profile of Prolia​ Source text for Eikon: Further company coverage:

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