Denosumab

Denosumab, faces a review Thursday by an outside panel of medical experts, and the FDA posted a review of the product on its Web site Tuesday.

Risks Seen on Bone Drug 2009

Denosumab is widely expected to gain approval in October, as it has shown success in six Phase III trials involving more than 11,000 patients, with a relatively clean safety profile.

Amgen Bone Drug Found Promising Thomas Gryta 2009

Denosumab is the first type of drug in its class and acts in a different manner than many other osteoporosis drugs, such as Boniva, Fosamax, and Reclast, that are known as bisphosphonates.

FDA Panel Suggests Limits for Amgen's Bone Drug 2009

Its osteoporosis drug Denosumab has proved effective in late-stage testing for treating bone fractures, with fewer side effects than existing treatments.

Rx for Ailing Investors? 2008

Denosumab, or d-mab, is the focus of the largest development program in Amgen's history, involving 19,000 patients in clinical tests of its bone-strengthening ability in patients with a variety of conditions.

Amgen Says Bone Drug 2008

Denosumab is considered the most promising product in the biotech giant's pipeline, and the results sent shares up after-hours.

Amgen Reports Positive Results 2008

Denosumab [or D-mab], a bone drug for osteoporosis and cancer, is something we're really excited about.

Amgen Navigates Crisis Over Drug 2008

Denosumab is the first significant drug candidate to emerge from a research-and-development overhaul Amgen initiated at the beginning of the decade to recharge a scientific enterprise that had faltered, after its early success with blood-building Epogen and Neupogen put Amgen on the map in the late 1980s.

Amgen to Present Data on Bone Drug 2008

Amgen's osteoporosis drug, Denosumab, is getting ready to come on the market in the next few years, and Amgen is already paving the way to push Fosamax's market share lower.

Cases Against Merck For Fosamax Jaw Bone Damage Growing 2006

Denosumab is also marketed under the trade name Xgeva.

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