Tag Archives: Approves

FDA Approves Dengvaxia (dengue vaccine) for the Prevention of Dengue Disease in Endemic Regions

FDA Approves Dengvaxia (dengue vaccine) for the Prevention of Dengue Disease in Endemic Regions Print this page May 01, 2019 — The U.S. Food and Drug Administration announced today the approval of Dengvaxia, the first vaccine approved for the prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in… Read More »

FDA Approves Eticovo (etanercept-ykro), a Biosimilar to Enbrel (etanercept)

News New Drugs FDA Approves Eticovo (etanercept-ykro), a Biosimilar to Enbrel (etanercept) Print this page April 26, 2019 The FDA has approved Eticovo (etanercept-ykro), a biosimilar to U.S.-licensed Enbrel (etanercept). A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-FDA approved biological product,… Read More »

FDA approves expanded label for Regeneron/Sanofi’s cholesterol drug

(Reuters) – The U.S. Food and Drug Administration on Friday approved Regeneron Pharmaceuticals Inc’s cholesterol drug Praluent as a treatment to cut the risk of heart attacks, stroke and other major cardiovascular events. The FDA’s decision will allow the drug, developed along with Sanofi SA, to be prescribed to reduce the overall risk of major… Read More »