The year 2007 was busy for the US FDA, with high-profile Phase III failures, and debates over the use of various drugs, which have put its regulatory process under ever closer scrutiny. Much of this attention has recently been focused on the field of prostate cancer, following the FDA#8217;s decision to issue an approvable letter for Dendreon#8217;s Provenge#174; (sipuleucel-T), the withdrawal of the NDA for GPC Biotech#8217;s satraplatin, and the suspension of Phase III trials of Novacea#8217;s Asentar#8482; (calcitriol). This therapy focus looks at the impact of these problems, current treatment options, and the status of the prostate cancer pipeline #8211; which looks strong, as there are 124 products in clinical trials.