Tag: Progenics Pharmaceuticals (PGNX)

Progenics: The FDA Accepted the NDA for Its Cancer Product Azedra® and Granted It Priority Review

Progenics: The FDA Accepted the NDA for Its Cancer Product Azedra® and Granted It Priority Review

Progenics Pharmaceuticals (PGNX) has good news today. The U.S. Food and Drug Administration (FDA) has accepted for review the firm’s New Drug Application (NDA) for its product Azedra® for recurrent and/or unresectable pheochromocytoma and paraganglioma — rare neuroendocrine tumors. The FDA has also granted Progenics’ request for Priority Review and has set an action date of April 30, 2018, under the Prescription Drug User Fee Act (PDUFA). The NDA is supported by data from a pivotal phase …