The President Donald Trump administration's request for Novavax Inc. to conduct new clinical trials for its COVID-19 vaccine has created uncertainty across the vaccine industry, potentially affecting ...

The Trump administration’s effort to impose new requirements on Novavax’s COVID-19 vaccine — the nation’s only traditional protein-based option for the coronavirus — is sowing uncert ...

At the insistence of Justice Neil Gorsuch, she withdrew the allegation that the other side had lied but held firm to the ...

Kennedy won Senate confirmation to his job, in part, by promising not to change the nation’s vaccine schedule. Since taking ...

Novavax is working with the FDA to meet additional requirements and hopes to secure full approval as soon as possible.

Novavax has not received an official response from the FDA related to the status of the BLA. The BLA was based on data from a phase III study, which showed the vaccine was safe and effective for ...

When asked if the delay resulted from "personnel being shuffled" at the FDA, Kennedy attributed it to the vaccine's composition. He said Novavax's single antigen approach "has never worked" for ...

By Kamal Choudhury (Reuters) -Vaccine maker Novavax's shares plunged nearly 20% at market close on Thursday, after Health and Human Services Secretary Robert F. Kennedy Jr. raised concerns about ...

This news follows Novavax's announcement last week that it is still awaiting a decision from the FDA regarding its Covid-19 vaccine approval application. Kennedy clarified that the delay in ...

Beyond the pending Novavax approval, the FDA must in the coming weeks advise Covid vaccine manufacturers on how to update their shots for the 2025-2026 respiratory season. The agency is also ...

Novavax intends to seek a business partner to ... And Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, who was instrumental in the development and ...