Lantheus Medical Imaging submitted a new drug application to the U.S. Food and Drug Administration (FDA) for its PyL (F-18 DCFPyL) radiopharmaceutical.
PyL is a prostate specific membrane antigen-targeted small-molecule PET radiopharmaceutical that aims to provide a view of prostate cancer. Lantheus is requesting priority review of PyL, which may shorten the FDA's review time to six months until acceptance. Typically, the review takes 10 months.