Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced today that the U.S. Food and Drug Administration (FDA) has accepted the file and granted priority review status to the Company's New Drug Application (NDA) for the investigational drug Torisel(TM) (temsirolimus). Wyeth Pharmaceuticals is seeking an indication for Torisel for the treatment of advanced renal cell carcinoma (RCC). A priority designation can be given to an NDA for a drug that, if approved, would be a significant improvement compared with existing treatments.The FDA previously granted fast track designation and orphan drug status for investigational temsirolimus for the treatment of advanced RCC.
Continue reading Drug on the fast track for FDA approval to treat advanced kidney cancer.
