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Drug Approvals

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Lutathera Clinical Development Timeline

Chronicle of the development and US FDA review of Advanced Accelerator Applications' lutetium Lu 177 dotatate for gastroenteropancreatic neuroendocrine tumors.


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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.


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Giapreza Reviewers

US FDA staff who participated in the review and approval of La Jolla Pharmaceutical's distributive shock treatment.


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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.

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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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Giapreza Clinical Development Timeline

Chronicle of the development and US FDA review of La Jolla Pharmaceutical's angiotensin II for increasing blood pressure in adults with septic or other distributive shock.


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