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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 ...
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 ...
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 ...
BioPharma Dive8d
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 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 ...
FDA Asks Vaccine Maker to Complete New Clinical Trial for Delayed Covid-19 Shot
A new randomized study could cost Novavax tens of millions of dollars, vaccine experts say ...
The Japan Times14hOpinion
RFK Jr.’s new vaccine scrutiny is alarming
Robert F. Kennedy Jr., who oversees the FDA, intends to set new regulatory standards vaccine manufacturers couldn’t possibly ...
Dermatology Advisor4d
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.
Novavax Shares Soar After FDA Request Raises Hope for COVID Vaccine Approval
The Department of Health and Human Services, which oversees FDA and other health agencies, did not immediately respond to a ...
Chicago Tribune7d
FDA scrutiny of Novavax COVID-19 vaccine sparks uncertainty about other shots
WASHINGTON — The Trump administration’s effort to impose new requirements on Novavax’s COVID-19 vaccine — the nation’s only traditional protein-based option for the coronavirus — is ...