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Editorial
Nature Biotechnology 26, 1 (1 January 2008) | doi:10.1038/nbt0108-1
The regulator disapproves
Abstract
Pressure is mounting on the US Food and Drug Administration (FDA) to explain its decision to ignore an advisory committee's positive recommendation for the cancer vaccine Provenge. In the coming weeks, it looks increasingly likely that the US Congress will launch an investigation into the circumstances behind the FDA's decision last May to delay approval of Provenge, a recombinant therapeutic vaccine developed by Dendreon for use in terminally ill patients with androgen-independent prostate cancer. Cancer patients have been exasperated by the agency's decision to ignore an advisory committee recommendation made in March, which gave the green light for full approval.
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