Dr. Marty Makary, the FDA’s commissioner, said the company is asking the agency to approve “a new product” based on old data. Novavax’s shot uses traditional protein-based vaccine ...

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

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

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

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 ...

Novavax's COVID-19-influenza vaccines show strong immune response in older adults, paving the way for regulatory approval.

FDA drug alerts in infectious diseases, including new drug approvals, safety warnings, recalls, and changes in indications.

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 U.S. Food and Drug Administration has approved a new lower-dose vaccine for active immunization against COVID-19 caused by severe acute respiratory syndrome coronavirus 2.

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 ...