BioCentury
ARTICLE | Clinical News

FDA extends review of Progenics' Azedra

March 30, 2018 3:36 PM UTC

Progenics Pharmaceuticals Inc. (NASDAQ:PGNX) said FDA will extend its review of an NDA for Azedra iobenguane I 131, postponing its PDUFA date to July 30 from April 30. The therapy is under Priority Review to treat malignant recurrent and/or unresectable pheochromocytoma and paraganglioma, which are types of neuroendocrine tumors (see BioCentury, Jan. 3).

Progenics said FDA needed more time to review additional CMC data the company has submitted...

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