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The FDA has accepted Sanofi’s application for expedited review of its once-daily, fixed-dose combination of insulin glargine and GLP-1 receptor agonist lixisenatide for Type 2 diabetes. Read More
The response letter is for Merck’s sNDAs for cholesterol drugs Zetia and Vytorin to reduce the risk of cardiovascular events in patients with coronary heart disease. Read More
Drug giant AstraZeneca has scored a big win in Europe, reeling in marketing authorization for Zurampic for patients with gout and a new dose of the heart medication Brilique. Read More
The FDA is offering more information on trial designs for sponsors developing therapies to treat allergic and nonallergic rhinitis and anthrax exposure. Read More