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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
There’s new uncertainty about updated COVID-19 shots this fall after the Trump administration’s handling of a shot from ...
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 ...
FDA asks Novavax for commitment on post-approval studies for COVID vaccine
Novavax on Wednesday said the U.S. Food and Drug Administration has asked the company to commit to produce more data on its ...
As FDA Delays Novavax' COVID Vaccine Approval, Patients Fight Back
Novavax has been available since 2022 through a pandemic-era Emergency Use Authorization. A decision on full approval – which ...
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 ...
Novavax told by FDA to conduct additional study for COVID vaccine - report
The U.S. FDA is asking Novavax (NASDAQ:NVAX) to conduct an additional randomized, controlled study of its COVID-19 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 Pharma13d
FDA asks Novavax for post-marketing data pledge amid stalled COVID shot review
On a recent call with analysts at BMO Capital Markets, a “former director” at the FDA’s Center for Biologics Evaluation and ...
FDA chief says they're looking at whether to approve COVID shots for next winter
The head of the Food and Drug Administration said Tuesday that the agency is now looking at whether it will still approve ...
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 ...
The Daily Record (Maryland)6d
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 ...