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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 ...
FDA to Mandate Placebo-Controlled Trials for New Vaccines
The US Food and Drug Administration will require all new vaccines to undergo placebo-controlled trials before approval — a ...
Moderna Shares Fall on Vaccine Sales Miss, Delay in FDA Review
Moderna Inc. shares declined after the company’s first-quarter vaccine sales missed estimates and it disclosed a delay in the ...
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." ...
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 ...
Fierce Pharma2d
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 ...
The American Journal of Managed Care1h
From “Super Skeptical” Beginnings, a New Immune-Modulatory Vaccine Awaits Phase 3 Results
IO Biotech's first-in-class vaccine performs double duty, killing cancer cells and enhancing the tumor microenvironment. A ...
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 ...
STAT3d
How Marty Makary’s FDA is embracing a more skeptical view of vaccines
FDA vaccine oversight is shifting, with increased scrutiny and mixed messaging sparking concerns among health experts.
RFK Jr. will order placebo testing for new vaccines, alarming health experts
The potential change outlined in a statement would require all new vaccines to undergo placebo testing, sparking concerns ...
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 ...
Cleveland.com4d
FDA scrutiny of Novavax COVID-19 vaccine sparks uncertainty about other shots
Novavax said Monday that the Food and Drug Administration was asking the company to run a new clinical trial of its vaccine after the agency grants full approval. The company said it had responded ...