Will the FDA Approve Xgeva – It is “Up In The Air”

Prior to the formal review, the FDA has raised questions about the ultimate approval of Amgen’s Xgeva (denosumab) for men with metastatic, advanced prostate cancer who have not yet developed metastasized to the bone. Xgeva has been shown to delay tumors spreading to bones, but it does not extend life, the holy grail of the [...]

Should Bisphosphonates Use Be Limited- An FDA Panel Waffles on Limiting Duration

A recent meeting of an FDA advisory committee has asked wants the FDA to limit the duration of bisphosphonate therapy for treatment of osteoporosis, but the committee could not agree on a time limit to recommend. […]

The Role of FDA Advisory Committees

As new treatments, drugs and medical devices come to market the FDA is charged with making sure that they are both safe and perform as represented. Products that come under review include items such as human and animal drugs, blood and other biological products, medical devices, and foods. The process of evaluating these products has [...]

By |2017-10-19T10:57:14-04:00August 5th, 2008|Advanced Prostate Cancer, Advocacy, FDA, Uncategorized|0 Comments