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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Moderna COVID Vaccine EUA For Kids Younger Than Six Will Be Big Test For FDA Efficacy Threshold
Application could be first major test of FDA’s comfort in authorizing a product with vaccine efficacy estimated to be at or below 50%. ‘Final components’ of the request to be submitted in the coming week. In interview, Moderna CMO Burton says results are ‘really strong.’
FTC Early Findings In PBM Investigation Coming By Mid-Summer, Chair Kahn Says
The agency is also poised to announce another development in its scrutiny of the drug patents listed in the FDA’s Orange Book.
ImmunityBio Will Aim Anktiva At Large Share Of Bladder Cancer Market
Execs Richard Adcock and Patrick Soon-Shiong told Scrip the company sees an addressable US population of about 20,000 and is aiming for ease of physician adoption.