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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 ...
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 ...
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” ...
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 Pharma2d
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 ...
STAT5d
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 ...
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 ...
CIDRAP5d
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 ...
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 ...
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 ...
Dermatology Advisor1d
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.
BioSpace1d
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 ...