Amgen's D-mab one step closer to EU approval

Amgen has won a big endorsement of its osteoporosis drug denosumab, which will be marketed as Prolia. The Committee for Medicinal Products for Human Use of the European Medicines Agency voted to support approval of the drug--widely expected to deliver blockbuster revenue to Amgen--as a treatment for postmenopausal women. And European regulators are likely to concur. Analysts generally agree that Amgen is likely to win the FDA's approval for the same patient group in the first quarter of next year. Report

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