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Friday, Apr 19, 2024

FDA Advisory Committee to Review Amgen Drug

The U.S. Food and Drug Administration asked biotech giant Amgen to participate in an advisory committee meeting in August to review the company’s experimental osteoporosis drug denosumab. The Thousand Oaks-based company is seeking approval for the drug’s use in the prevention and treatment of postmenopausal osteoporosis and prevention and treatment of bone loss in patients undergoing hormone ablation for either prostate or breast cancer. The meeting is scheduled for August 13, and the FDA is expected to make a decision on denosumab by October, according to the Associated Press. The FDA provisionally approved the trade name Prolia for denosumab. Amgen is also seeking marketing approval in Europe, Canada and elsewhere. Shares of Amgen Inc. closed down at $50.99. Eric Billingsley

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