New Drug Applications Archive - January 2016
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January 4, 2016
January 5, 2016
January 7, 2016
January 8, 2016
January 12, 2016
- Gilead Submits New Drug Application to U.S. FDA for Tenofovir Alafenamide (TAF) for the Treatment of Chronic Hepatitis B
- Titan Pharmaceuticals And Braeburn Pharmaceuticals Announce FDA Advisory Committee Recommends Approval Of Probuphine
- FDA Grants Priority Review for Venetoclax New Drug Application
January 14, 2016
- FDA Issues Complete Response Letter for Kyndrisa for Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping
- Adamis Pharmaceuticals Announces FDA Acceptance of Resubmission of Its Epinephrine Pre-Filled Syringe NDA
January 15, 2016
January 19, 2016
January 25, 2016
- FDA Accepts Amgen's Biosimilar Biologics License Application For ABP 501
- Shire Resubmits New Drug Application for Lifitegrast to U.S. FDA
