Lantheus Holdings Announces Acceptance and Priority Review of New Drug Application for PyLTM (18F-DCFPyL), a PSMA-Targeted Prostate Cancer PET Imaging Agent

PDUFA action date of May 28, 2021, assigned by the U.S. Food and Drug Administration

San Francisco, California (UroToday.com) — Lantheus Holdings, Inc., the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture, and commercialization of innovative diagnostic and therapeutic agents and products, announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for PyL^TM (18F-DCFPyL), a prostate-specific membrane antigen (PSMA)-targeted positron emission tomography (PET) imaging agent for prostate cancer.