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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 Pharma9h
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 ...
FDA chief 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 ...
BioPharma Dive2h
Moderna combination flu, COVID shot delayed amid FDA scrutiny
Additional data required by the FDA are the latest evidence of what one analyst described as a “higher bar” for vaccines.
FDA scrutiny of Novavax COVID-19 vaccine sparks uncertainty about other shots
Kennedy won Senate confirmation to his job, in part, by promising not to change the nation’s vaccine schedule. Since taking ...
Fierce Biotech11h
Moderna's flu/COVID combination vax hit by deprioritization, FDA delay as R&D spend sinks 19%
Moderna is deprioritizing its flu/COVID combination vaccine in younger adults amid a push to cut about $1.5 billion from its ...
HHS to require placebo testing of ‘all new vaccines,’ raising questions about approval of updated Covid-19 shots
The US Department of Health and Human Services said it will require that all new vaccines be tested in placebo-controlled ...
FDA commissioner: No major reorganization, just smart reforms
Dr. Marty Makary had just finished his last surgery at Johns Hopkins when he stepped into one of the most powerful roles in ...
What's holding up new COVID booster guidance from the FDA
The Food and Drug Administration was set to release new guidance on COVID booster shots ahead of the fall season, but that's ...
Claims That the FDA Has Approved Ivermectin to Treat COVID-19 Are False
At the peak of the COVID-19 pandemic, many vaccine skeptics turned to ivermectin, a medication proven to fight off parasitic ...
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 ...
ABC News3d
FDA scrutiny of Novavax COVID-19 vaccine sparks uncertainty about other shots
Because the coronavirus continually mutates, manufacturers follow instructions from FDA to make one change each year to their recipe — which strain to target — just like flu vaccines.