Last week the FDA granted full approval of Novavax's COVID-19 vaccine but with major restrictions on who can get it — and Tuesday's guidance mirrors those restrictions. The approval came after ...

Novavax, Inc. faces profitability challenges despite a promising tech platform, with uncertain revenue streams. Click for my ...

Gaithersburg-based Novavax makes the nation’s only traditional protein-based coronavirus vaccine – and until now it had emergency authorization from FDA for use in anyone 12 and older.

Novavax's combo and standalone flu vaccines showed strong immune responses and good safety in a Phase 3 trial of adults 65 ...

Novavax (NasdaqGS:NVAX) recently reported initial results from its Phase 3 trial for its COVID-19-Influenza Combination and seasonal influenza vaccines, which showed immune responses comparable to ...

Government advisers are split on whether drugmakers should update their COVID-19 vaccines to better protect Americans this fall and winter.

Jefferies analysts said the approval was largely expected and an “incremental positive” for Moderna amid questions about the FDA’s attitude toward mRNA and COVID-19 vaccines that have investors ...

The FDA’s approval was based on a study of 11,400 people age 12 and older that compared the new low-dose vaccine with Moderna’s existing vaccine. It found the new vaccine was safe and was at least as ...

In an editorial article published in the New England Journal of Medicine, Dr. Vinay Prasad, the newly appointed head of the Center for Biologics Evaluation and research at the FDA, and Dr. Martin ...