News

Novavax: Grandiose Ambitions, Smart Strategy, But FDA Decision Adds To Challenges
Novavax shows financial improvement but faces vaccine challenges. Read why I rated NVAX stock as 'Hold' and what risks and ...
BioPharma Dive26m
Novavax says vaccine application still ‘approvable,’ despite FDA delay
Comments over the weekend by FDA chief Martin Makary suggest the agency views Novavax’s updated COVID shot as a “new product” ...
FDA may ask Novavax to conduct additional trials of its Covid-19 vaccine to receive full approval
The US Food and Drug Administration has discussed with vaccine-maker Novavax the need for an additional trial of its Covid-19 ...
US FDA asks Novavax to complete new clinical trial for delayed COVID-19 shot, WSJ reports
Federal regulators have asked Novavax to complete an additional clinical trial on its COVID-19 vaccine after previously ...
Infectious Disease Advisor3h
Novavax COVID-19 Vaccine Moves Closer to Full FDA Approval
Novavax’s COVID-19 vaccine could soon receive full approval from the United States Food and Drug Administration.
Novavax Falls on Report That FDA Wants New Covid Vaccine Trial
Novavax Inc. shares fell after the Wall Street Journal reported that US regulators asked the company to conduct another ...
As FDA delays Novavax' COVID vaccine approval, patients fight back
Thousands of Americans campaigning for the Novavax COVID-19 booster got some good news this week: the FDA signaled it might ...
FDA still negotiating whether to grant full approval to Novavax COVID-19 vaccine
The U.S. Food and Drug Administration (FDA) is still negotiating whether to grant full approval to Novavax's COVID-19 vaccine ...
FDA Asks Vaccine Maker to Complete New Clinical Trial for Delayed Covid-19 Shot
A new randomized study could cost Novavax tens of millions of dollars, vaccine experts say ...
Novavax says its COVID-19 shot is on track for full FDA approval after delay
Novavax says its closely watched COVID-19 vaccine is on track for full U.S. approval after additional discussions with the ...
CNN2d
FDA may ask Novavax to conduct additional trials of its Covid-19 vaccine to receive full 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.