Recent And Upcoming FDA Advisory Committee Meetings
Executive Summary
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
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Janssen’s Esketamine Needs Better Defined REMS, US FDA Panel Says
Advisory committee overwhelmingly endorses approval for patients with treatment-resistant depression but says proposed Risk Evaluation and Mitigation Strategy needs refinement, including clarifying the types of facilities where the drug will be administered.
Biogen Sees Improving Momentum In Slow Leqembi Launch
Sales of the company’s new drugs have a lot of growing to do to make up for older products’ declines, but Biogen highlighted signs of strength for new launches in its Q1 report.
Vivalink Partners With Rett Syndrome Research Trust To Accelerate Research In Rare Disease
Vivalink will provide ECG wearable technology to monitor patients in RSRT’s Vibrant study, which is aimed at assessing autonomic dysfunction in children with Rett syndrome.