New Drug Applications Archive - March 2015
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March 2, 2015
- Xadago (safinamide) NDA Accepted for Filing by the U.S. FDA
- Shire Submits NDA to the FDA for Approval of Lifitegrast For Treatment of Dry Eye Disease in Adults
- Boehringer Ingelheim Submits BLA to FDA for Idarucizumab, Investigational Specific Reversal Agent for Pradaxa
March 3, 2015
March 4, 2015
March 9, 2015
- AcelRx Provides Regulatory Update on Zalviso
- Kythera Biopharmaceuticals Announces FDA Advisory Committee Unanimously Recommends to Approve ATX-101
March 12, 2015
March 13, 2015
March 14, 2015
March 15, 2015
- Sanofi and Regeneron Announce 18-Month Results of ODYSSEY LONG TERM Trial With Praluent (Alirocumab)
- Amgen Publishes Safety Analysis Of Investigational Cholesterol-Lowering Medication Repatha (Evolocumab)
March 19, 2015
- Sanofi Announces Top-Line Results for Cardiovascular Outcomes Study of Lyxumia (Lixisenatide)
- Nicox Receives Orphan Drug Designation from FDA for Naproxcinod in Duchenne Muscular Dystrophy
