Earlier this summer the FDA asked Moderna for more efficacy data on its flu vaccine before it could review an mRNA-based ...

Novavax originally showed its vaccine was safe and effective in a 30,000-person clinical trial. The FDA had been on track to grant Novavax full approval – without restrictions -- by its April 1 ...

The new memos from the Food and Drug Administration show how the agency’s vaccine chief, Dr. Vinay Prasad, personally intervened to place restrictions on COVID shots from vaccine makers Novavax and ...

In a July 9 memo, the director of the FDA's Center for Biologics Evaluation and Research contended there was not enough ...

Novavax expects the 2025-2026 Nuvaxovid™ formula to be ready for commercial delivery in the U.S. this fall in partnership with Sanofi, pending strain recommendation from the FDA Vaccines and ...

Novavax has submitted an application to the Food and Drug Administration for Emergency Use Authorization of its COVID-19 vaccine as a booster in adults that can be used on top of its primary ...

The Food and Drug Administration (FDA) signed off Wednesday on an emergency use authorization for the Novavax COVID-19 vaccine for individuals 18 years of age and older.

Those limits match the terms FDA recently approved for Novavax’s shot, Nuvaxovid and Moderna’s mNexspike. Novavax’s vaccine is the only protein-based coronavirus vaccine available in the U.S ...

Newly released documents show the FDA’s vaccine chief, Dr. Vinay Prasad, intervened to restrict approval of two new shots from vaccine makers Novavax and Moderna.