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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
The Trump administration's effort to impose new requirements on Novavax's COVID-19 vaccine — the nation's only traditional ...
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 Pharma1d
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” ...
Dermatology Advisor8h
Novavax COVID Vaccine Moves Closer to Full FDA Approval
The FDA is expected to unpause the only protein-based COVID-19 vaccine's transition from emergency approval to full approval.
STAT4d
U.S. health officials inject new uncertainty into approval process for Covid boosters
Confusion over the FDA delay in granting full approval to Novavax’s Covid-19 vaccine deepened over the weekend, with possible ...
BioSpace9h
FDA to Rehire Some Travel Staff as Lapses Begin to Show: AP
Some 20 travel staff at the FDA, who made arrangements for the regulator’s inspectors, will be getting their jobs back, as ...
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 ...
Novavax shares soar after FDA request raises hope for COVID vaccine approval
Novavax said on Wednesday U.S. regulators asked the company to produce more data on its COVID-19 vaccine if it gets full ...
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 ...