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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 ...
FDA scrutiny of Novavax COVID-19 vaccine sparks uncertainty about other shots
Novavax said Monday that the Food and Drug Administration was asking the company to run a new clinical trial of its vaccine.
COVID vaccine boosters called into question by FDA chief: ‘Void of data’
Dr. Marty Makary, chief of the FDA, has expressed doubts about the agency approving the COVID-19 vaccine for winter, stating ...
Fierce Pharma19h
FDA puts up placebo testing requirement for new vaccines, potentially hitting COVID shot makers the hardest: reports
“Under Secretary Kennedy’s leadership, all new vaccines will undergo safety testing in placebo-controlled trials prior to ...
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” ...
CIDRAP3d
More FDA uncertainty roils full approval for Novavax COVID vaccine
Novavax's COVID vaccine was approved under an emergency use authorization in August 2022, and the company has pursued full ...
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 ...
Novavax says its COVID-19 shot is on track for full FDA approval after delay
Novavax's closely watched COVID-19 vaccine is on track for full approval after additional discussions with the Food and Drug ...
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 ...
STAT5d
U.S. health officials inject new uncertainty into approval process for Covid boosters
Confusion over the Food and Drug Administration’s delay in granting full approval to Novavax’s Covid-19 vaccine ... took to social media to defend the FDA’s controversial handling of the ...
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 ...
Pulmonology Advisor1d
Novavax COVID Vaccine Moves Closer to Full FDA Approval
Novavax's protein-only vaccine is once again expected to move from emergency approval to full approval status following a pause.