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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 ...
BioSpace2h
HHS To Require Placebo-Controlled Trials for All New Vaccines in ‘Radical Departure’ From Past
The new policy, revealed by the Department of Health and Human Services on Wednesday, would make vaccines “less available and ...
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 ...
STAT1d
8 possible indicators of how RFK Jr.’s HHS will handle vaccine policy
Here are eight possible indicators of how health secretary Robert F. Kennedy Jr. may handle U.S. vaccine policy in coming ...
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 ...
Fierce Pharma4h
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 ...
BioPharma Dive3d
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” ...
Fierce Pharma2h
Moderna targets more cost cuts amid broader vaccine market uncertainty under HHS secretary RFK Jr.
On a Thursday conference call with investors, Moderna CFO Jamey Mock outlined a roadmap for the mRNA specialist to lower its ...
pharmaphorum2d
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 COVID Vaccine Moves Closer to Full FDA Approval
Under emergency use, vaccines can be removed even after a health emergency is considered to be over. Full approval from the ...
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 ...
Chicago Tribune2d
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 ...