Novavax on Thursday tried to calm investors spooked by the delay of full approval of its COVID vaccine shot by U.S.

Novavax said on Thursday discussions with the U.S. health regulator on its COVID-19 shot are ongoing and a pathway to ...

After more than a month of speculation over how the FDA will rule on Novavax’s application for an updated formulation of its ...

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” ...

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

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 ...

First, to the best of your knowledge, is the post-marketing clinical trial requirement specific to Novavax's BLA filing or do you expect FDA will ask all COVID-19 vaccines, including the mRNA ...