The Trump administration’s effort to impose new requirements on Novavax’s COVID-19 vaccine — the nation’s only traditional ...

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

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

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

The FDA is expected to unpause the only protein-based COVID-19 vaccine's transition from emergency approval to full approval.

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 ...

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 ...

CHICAGO, April 24 (Reuters) - Thousands of Americans campaigning for the Novavax (NVAX.O), opens new tab COVID-19 booster got some good news this week: the FDA signaled it might still win approval ...

The terms need to be negotiated before Novavax’s vaccine could be granted full approval, the source said, declining to be named because they weren’t authorized to speak on behalf of the FDA.