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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 ...
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 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 ...
BioPharma Dive7d
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” ...
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 ...
Kennedy Issues Demands for Vaccine Approvals That Could Affect Fall Covid Boosters
The plans amount to an extraordinary flex of Robert F. Kennedy Jr.’s power as health secretary to make decisions ordinarily ...
pharmaphorum6d
Does the Novavax delay augur a COVID vaccine policy change?
In addition, HHS Secretary Robert F. Kennedy Jr addressed the delay in Novavax's approval in a CBS interview earlier this ...
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 ...
The Daily Record (Maryland)4d
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 protein-based option for the coronavirus — is sowing ...