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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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Accelerated Approval: US FDA Panel To Reconsider Six Indications For Checkpoint Inhibitors

Oncologic Drugs Advisory Committee will meet for three days in April to consider whether indications for Tecentriq, Keytruda and Opdivo should remain on label despite failure to confirm clinical benefit; review is part of the Oncology Center of Excellence’s ‘industry-wide evaluation’ of accelerated approvals, which has led to withdrawals of four other PD-1/L-1 inhibitor claims.

UK Chooses mRNA Boosters For COVID-19 Vaccination Campaign

In making its recommendations for the autumn vaccination program against COVID-19, the UK’s JCVI says Novavax’s Nuvaxovid could be used in exceptional circumstances, but there is no room for AstraZeneca’s Vaxzevria.

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