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Found 2 results

  1. Biotech_Forecast
    Saint-Genis-Pouilly, France - June 27, 2016 – Advanced Accelerator Applications S.A. (NASDAQ:AAAP) (“AAA” or “the Company”), an international specialist in Molecular Nuclear Medicine (MNM), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) and granted Priority Review for Lutathera, a Lu-177-labeled somatostatin analogue peptide currently under development for the treatment of gastro entero pancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults. The Prescription Drug User Fee Act (PDUFA) target action date is December 28, 2016.
  2. Biotech_Forecast
    25 February 2016, Saint-Genis-Pouilly, France – Advanced Accelerator Applications S.A. (NASDAQ:AAAP) (“AAA” or “the Company”), an international specialist in molecular nuclear medicine, today announced both updated data from the pivotal Phase 3 NETTER-1 study investigating the treatment of Lutathera (177-Lu-Dotatate) in patients with inoperable, progressive, somatostatin receptor positive midgut neuroendocrine tumors (midgut NETs) as well as Prescription Drug User Fee Act (PDUFA) date update for Somakit-TATE New Drug Application (NDA).