Tag Archive: clinical benefit

Aug 11 2010

Accelerated Approval

Image via Wikipedia One must strike the right balance between speed and quality. – Clare Short Accelerated approval has been in the news for a while, so it seems like a good time to go over some of the basics:  What is accelerated approval and how does it work? The process is defined in 21 …

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May 12 2010

Approval of Therapeutic Cancer Vaccines

Last month, Dendreon was granted approval for Provenge®, the first cell based cancer vaccine for treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.  Provenge is the first cancer treatment that utilizes the strength of the patient’s own immune system to fight tumors.  This approval could mark the beginning of a …

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