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The European Medicines Agency is recommending the first-ever malaria vaccine, GSK’s Mosquirix, as a protection for children ages six weeks to 17 months in sub-Saharan Africa. Read More
The FDA Friday gave the green light to Sanofi and Regeneron’s cholesterol-lowering drug Praluent, beating Amgen’s Repatha in a race to be the first PCSK9 inhibitor in the U.S. Read More
The European Medicines Agency has recommended approval of Shire’s Intuniv to treat attention deficit hyperactivity disorder — potentially breathing new life into the drug, which is facing new competition from generics in the U.S. Read More
The European Commission has approved Bristol-Myers Squibb’s PD-1 inhibitor Nivolumab BMS for the treatment of advanced or metastatic squamous non-small cell lung cancer, the second indication approved for the drug in a month. Read More
Bristol-Myers Squibb has received breakthrough therapy designation from the FDA for its first-in-class investigational BMS-663068 compound for use in preventing HIV infection. Read More