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US FDA’s COVID Whirlwind: Pfizer Vaccine Adcom Set; Monoclonal EUAs Cleared; Trump Aggrieved

 
• By Nielsen Hobbs

Warp Speed’s Slaoui predicts vaccinations starting within days of the 10 December advisory committee for Pfizer’s coronavirus vaccine. Regeneron’s monoclonal cocktail follows Lilly’s antibody product with an EUA.

FDA entrance sign 2016

If ever a US FDA advisory committee could be very dramatic but also just a complete formality, the review of Pfizer Inc.’s COVID vaccine slated for 10 December would fit that bill. The company announced it would file for emergency use authorization on the morning of 20 November, FDA announced that evening it had scheduled an advisory committee, and Operation Warp Speed chief science officer Moncef Slaoui went on TV on 22 November to say that the vaccine could be cleared the day after the advisory committee.

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Leqembi Launch Set For Germany & Austria After Winning EU Approval At Last

 
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US FDA User Fee Collection Safe In Preliminary Trump 2026 Budget Plan

 
• By Cathy Kelly

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New EU Approvals

 
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US CDC Panel Recommends Some 50-59 Year-Olds For RSV Vaccination

 
• By Bridget Silverman

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