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New Data Needed in Preventive Use

FDA Wants More Details on Dmab Before Giving Amgen a Go-Ahead

By Donna Young

Tuesday, October 20, 2009
The FDA needs more details from Amgen Inc. about its postmarketing safety surveillance study program before regulators will approve Prolia (denosumab) as a treatment for postmenopausal osteoporosis, the company said Monday. (BioWorld Today)

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