Merck & Co.’s BLA for Gardasil, the investigational cervical cancer vaccine, has been accepted and granted priority review by the FDA. A priority designation is intended for products that address unmet medical needs. Under the Prescription Drug User Fee Act (PDUFA), for BLAs filed in 2005, the FDA’s goal is to review and act on BLAs designated as priority review within six months of receipt. The FDA has informed Merck that the review goal date is June 8, 2006. Merck has also...