The unusual move at FDA comes shortly after the agency's longtime vaccine chief was forced out over disagreements with Makary ...

There’s new uncertainty about updated COVID-19 shots this fall after the Trump administration’s handling of a shot from ...

The US Food and Drug Administration has discussed with vaccine-maker Novavax the need for an additional trial of its Covid-19 ...

Comments over the weekend by FDA chief Martin Makary suggest the agency views Novavax’s updated COVID shot as a “new product” ...

Novavax’s COVID-19 vaccine could soon receive full approval from the United States Food and Drug Administration.

However, as noted in the news article, Novavax can and certainly will try to negotiate for a resolution with the FDA that will be workable for it and Sanofi so that Sanofi can pursue its rollout ...

WASHINGTON — 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 ...

The President Donald Trump administration's request for Novavax Inc. to conduct new clinical trials for its COVID-19 vaccine ...

The FDA was on track to grant Novavax full approval by its April 1 target date, according to two people with direct knowledge of the situation who spoke on condition of anonymity to discuss ...