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FDA Calendar
Event DateSymbolDrug NameEvent Name
07/21/17PBYIPB272 (Neratinib) (NDA)FDA decision on PB272 for the extended adjuvant treatment of patients with early stage HER2-overexpressed/amplified breast cancer
07/19/17AMGNRomosozumab (BLA)FDA decision on Romosozumab for the treatment of osteoporosis in postmenopausal women at increased risk of fracture
07/19/17OCULDEXTENZA (NDA resubmission)FDA decision on DEXTENZA for treatment of ocular pain occurring after ophthalmic surgery
06/30/17RDUSAbaloparatide-SC (NDA)FDA decision on Abaloparatide–SC for postmenopausal women with osteoporosis
06/30/17ARRYBinimetinib (NDA)FDA decision on Binimetinib for patients with NRAS-mutant melanoma.
06/30/17TSRONiraparib (NDA)FDA decision on Niraparib a treatment for patients with recurrent epithelial ovarian for treatment of fallopian tube, or primary peritoneal cancer
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FDA Device Approval
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