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US FDA advisers to discuss COVID-19 vaccine recommendations on May 22
The U.S. Food and Drug Administration said on Wednesday it will hold a meeting of experts on May 22 to discuss COVID-19 ...
BioPharma Dive16h
FDA set to meet this month on COVID vaccines
The advisory committee meeting is an important step in the process of readying boosters for the fall and winter season, but ...
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 ...
Fierce Pharma6d
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 ...
In reversal, FDA rehires staff tasked with releasing public records
The FDA has rehired at least some workers tasked with releasing public records generated by the agency’s regulatory ...
RFK Jr. calls for 'new' vaccines to undergo placebo-controlled trials
A Department of Health and Human Services spokesperson called the move "a radical departure from past practices." ...
Updated Covid vaccines for the fall may be in jeopardy under Kennedy's new rules
If the FDA deems Pfizer’s and Moderna’s updated vaccines “new” products, it’s extremely unlikely the doses would be ready for ...