Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered
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US FDA does not raise any major concerns about study’s design or results to support cardiovascular risk reduction claim for Novo Nordisk’s GLP-1 agonist liraglutide ahead of advisory committee, but agency gives close scrutiny to non-CV safety events of interest.
Pfizer's Mylotarg attempt to return to US market is first up for FDA's Oncologic Drugs Advisory Committee, followed by Novartis's CAR-T therapy. ODAC will then give half-day review to Amgen's and Mylan's biosimilars, suggesting FDA is increasingly comfortable with the product category.
Valneva is scaling up manufacture of its coronavirus vaccine alongside the clinical development program, with a view to meeting its commitment to provide millions of doses for use in the UK and the EU.