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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: Initiating Hold Rating After Strong, But Misunderstood Q1 2025 Earnings Beat
Novavax is undervalued, presenting an attractive risk-reward profile for long-term investors. Click here to find out why NVAX ...
Novavax says talks with FDA on COVID vaccine approval ongoing calming investor fears
Novavax on Thursday tried to calm investors spooked by the delay of full approval of its COVID vaccine shot by U.S.
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 ...
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 ...
'Show me the data': FDA commissioner reacts to question about Covid vaccine for young Americans
Vaccine maker Novavax is seeking to convert the 2022 emergency authorization of its Covid-19 vaccine into full approval. Yet ...
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 ...
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 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 before it will consider approving it. The prospect is a major setback for the ...
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FDA may ask Novavax to conduct additional trials of its Covid-19 vaccine to receive full approval
"We can confirm we have responded to the FDA's Post Marketing Commitment (PMC) request and are awaiting feedback from the agency," Novavax said in a statement Friday. "PMCs are not unusual with ...