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.
You may also be interested in...
CBER director said unlicensed stem cell clinics often report adverse events not made public, which is a concern under Right To Try.
Fresenius Kabi’s Omegaven is most recent of 13 approvals, including three with breakthrough therapy designations, where FDA has relied on real world evidence to make a regulatory decision about efficacy.
US FDA staff who participated in the review and approval of La Jolla Pharmaceutical's distributive shock treatment.