Dendreon Crosses Fingers, Knocks on Wood, And Resubmits Provenge To FDA
This article was originally published in Pharmaceutical Approvals Monthly
Dendreon resubmitted its prostate cancer treatment Provenge (sipuleucel-T) to FDA Nov. 2, two and a half years after the agency disagreed with an advisory panel and rejected the vaccine, which targets metastatic, castration-resistant forms of the disease.
You may also be interested in...
With strong overall survival data in hand for its prostate cancer vaccine, Seattle biotech takes advantage of increased investor interest.
FDA is requesting additional clinical data to support the efficacy of Dendreon’s BLA.
Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011