Neos' ADHD Drug Won't Launch Until 2017 As FDA Requires Clinical-Commercial Bridging Study
This article was originally published in The Pink Sheet Daily
Complete response letter seeks assessment of food effect of Cotempla XR-ODT (methylphenidate extended-release orally disintegrating tablets).
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The latest drug development news and highlights from our FDA Performance Tracker.
Panel expects to review five respiratory syncytial virus vaccines and vote on one or two of them in June 2023 and others four months later. Sanofi presents results of three clinical trials of its monoclonal antibody nirsevimab, which is on track to be the second RSV prophylaxis for infants.