Search the Community
Showing results for tags 'pdufa'.
Found 5 results
-
Advanced Accelerator Applications (AAAP) PDUFA of Lutathera for Neuroendocrine Tumors
Biotech_Forecast posted an event in Biotech Events
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.-
- advanced accelerator applications
- pdufa
- (and 2 more)
-
ADMA Biologics (ADMA) PDUFA of RI-002 for Infection Prevention in Primary Immunodeficiency Disease
Biotech Forecast posted an event in Biotech Events
-
- adma biologics
- adma
-
(and 1 more)
Tagged with:
-
-
Sarepta (SRPT) PDUFA of Eteplirsen for Duchenne Muscular Dystrophy
Biotech Forecast posted an event in Biotech Events
-
Anacor (ANAC) PDUFA of Crisaborole Topical Ointment for Mild-to-Moderate Atopic Dermatitis
Biotech Forecast posted an event in Biotech Events