Giapreza Reviewers
Executive Summary
US FDA staff who participated in the review and approval of La Jolla Pharmaceutical's distributive shock treatment.
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Lutathera Reviewers
US FDA staff who participated in the review and approval of AAA's treatment for somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors.
Lutathera Clinical Development Timeline
Chronicle of the development and US FDA review of Advanced Accelerator Applications' lutetium Lu 177 dotatate for gastroenteropancreatic neuroendocrine tumors.
Lutathera’s Broad Tumor Indication Aided By Expanded Access Data
US FDA’s approval of Advanced Accelerator Applications’ radiopharmaceutical for gastroenteropancreatic neuroendocrine tumors was driven by robust Phase III study results in midgut carcinoid tumors and data from an investigator-initiated, expanded access study in the Netherlands that enrolled patients with a host of other neuroendocrine tumor types.