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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 licensure—a radical departure from past practices,” the Department of Health and Human Services (HHS) said in a statement to CNN.
Dr. Marty Makary, chief of the FDA, has expressed doubts about the agency approving the COVID-19 vaccine for winter, stating ...
The plans amount to an extraordinary flex of Robert F. Kennedy Jr.’s power as health secretary to make decisions ordinarily ...
The Trump administration's effort to impose new requirements on Novavax's COVID-19 vaccine — the nation's only traditional ...
In a shift away from next-generation Covid-19 vaccines, the Trump administration is investing $500 million in a vaccine ...
The FDA is expected to unpause the only protein-based COVID-19 vaccine's transition from emergency approval to full approval.
If the FDA deems Pfizer’s and Moderna’s updated vaccines “new” products, it’s extremely unlikely the doses would be ready for ...
Additional data required by the FDA are the latest evidence of what one analyst described as a “higher bar” for vaccines.
A Department of Health and Human Services spokesperson called the move "a radical departure from past practices." ...
Kennedy and FDA Commissioner Marty Makary’s approach to assessing vaccines could put Covid boosters out of reach.
Comments over the weekend by FDA chief Martin Makary suggest the agency views Novavax’s updated COVID shot as a “new product” ...
The US Department of Health and Human Services said Thursday that it aims to accomplish within four years a scientific feat ...
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