Vaccine maker Novavax is seeking to convert the 2022 emergency authorization of its Covid-19 vaccine into full approval. Yet ...

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The FDA expects to fully integrate its AI approach by June 30, though its different centers have been instructed to start the ...

The missed PDUFA adds to a string of delays at the FDA in recent weeks, including at least two other missed target action ...

A new vaccine developed by Moderna aims to protect against both flu and COVID-19 with just one shot. Early studies suggest ...