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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.
Fierce Pharma9h
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 ...
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 ...
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 ...
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 ...
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 Dive2h
Moderna combination flu, COVID shot delayed amid FDA scrutiny
Additional data required by the FDA are the latest evidence of what one analyst described as a “higher bar” for vaccines.
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” ...
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 ...
ABC News3d
FDA scrutiny of Novavax COVID-19 vaccine sparks uncertainty about other shots
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 ...