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FDA starts review of Sanofi, AZ antibody for RSV prevention

January 5, 2023

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If approved, nirsevimab would become the first and only single-dose, passive immunisation for a broad infant population, including those born healthy, at term or preterm, or with specific health conditions, according to the two partners.

The antibody has already been recommended for approval in the EU, where it has the proposed trade name of Beyfortus, with a final decision expected in the coming weeks.

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