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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.’

FDA Grants EUA To First OTC Test That Detects COVID-19, Flu, RSV

The US agency has issued an emergency use authorization to Labcorp for its over-the-counter test that detects COVID-19, flu and respiratory syncytial virus.

AstraZeneca Buys Into COVID-19 Antibodies From Newly Launched RQ Bio

The big pharma company and its new partner both expect demand to continue for pre-exposure prophylaxis antibody therapies, for COVID-19 and beyond.

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