Sanofi's fixed-ratio combination of Lantus (insulin glargine) and the GLP-1 agonist lixisenatide got a passing grade from FDA's external advisors May 25, but the company may need to redesign the dosing device before the product can reach market.
Lantus/Lixisenatide Combo Gets FDA Panel Nod, But Not Sanofi's Device
Pen for iGlarLixi should be redesigned to reduce risk of confusion and medication errors, advisory committee members say.
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Pink Sheet reporter and editors discuss FDA Commissioner Martin Makary’s decision to have one of his assistants lead negotiations for Novavax’s delayed COVID-19 vaccine review, as well as some recent missed review deadlines, which may be the result of recent FDA cuts.