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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Chronicle of the development and US FDA review of Advanced Accelerator Applications' lutetium Lu 177 dotatate for gastroenteropancreatic neuroendocrine tumors.
Lutathera Reviewers
US FDA staff who participated in the review and approval of AAA's treatment for somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors.
La Jolla’s Giapreza: Emergency Use Requests Sped US FDA Approval For Septic Shock
After publication of ATHOS-3 study results, agency received several requests from medical community for emergency use in hospitalized patients with shock and hypotension unresponsive to available therapy, spurring FDA to take an approval action two months ahead of user fee goal date.
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