As Amgen's Prolia Goes, So Goes The Market: Reaction To AC Recs
FDA and the Reproductive Health Drugs Advisory Committee's focus on small imbalances in Amgen's trial data for Prolia (denosumab) sparked disparate reactions on the Street, with some analysts trimming their estimates and others holding tight
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Denosumab will be indicated for use in postmenopausal women with osteoporosis who are at high risk for fractures.
FDA handed Amgen a complete response letter for Prolia, but the company has an armamentarium for handling the agency's requests.
Amgen brings a key commercial advantage to negotiations with FDA over a REMS plan for its osteoporosis drug denosumab: regulatory experience