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Amgen’s Xgeva For Castration-Resistant Prostate Cancer Faces Panel Review Without Overall Survival Advantage

This article was originally published in The Pink Sheet Daily

Executive Summary

Delaying or preventing bone metastasis is an important clinical benefit for patients, an FDA official said recently. The Oncologic Drugs Advisory Committee will share its opinion about the product on Feb. 8.

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Xgeva Prostate Cancer Claim May Not Benefit Beyond Existing Cancer Indication, FDA Says

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Ferraprox Advisory Cmte: Can Risk Management Overcome Safety, Dosing Worries?

ApoPharma's transfusional iron overload treatment has been approved in Europe since 1999, but FDA sent a "complete response" letter in 2009.


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