News

FDA Commissioner: No Major Reorganization, Just Smart Reforms
In an exclusive interview with physician and writer Dr. Jeremy Faust on Substack, Makary opened up about his first weeks on ...
FDA to rehire fired staffers who booked inspection trips, but other workers remain in limbo
The Food and Drug Administration is again trying to rehire some staffers who were recently fired amid mass layoffs at the ...
Burger Recall Update as FDA Sets Highest Risk Level
A recall of seafood burgers by the Connecticut based company Caraluzzi's Markets has been issued a Class I risk ...
Neuralink's speech restoration device gets FDA's 'breakthrough' tag
Neuralink has received the U.S. Food and Drug Administration's "breakthrough" tag for its device to restore communication for ...
FDA to undo some layoffs, after cuts to inspections and drug safety
Multiple current and laid-off FDA employees said the abrupt layoffs had resulted in delays and disruptions to the agency's ...
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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 ...
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 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 ...
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FDA Misses Another Deadline Amid Staff Exodus, Structural Disruptions
The FDA has lost several senior employees in recent weeks, including some who have been at the agency for more than two ...
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Federal Court Strikes Down FDA Rule on LDTs
On March 31, 2025, the U.S. District Court for the Eastern District of Texas ruled that the Food and Drug Administration (FDA ...
FDA to Mandate Placebo-Controlled Trials for New Vaccines
The US Food and Drug Administration will require all new vaccines go through placebo-controlled studies before they are ...
FDA Approves Zevaskyn for Rare, Genetic Skin Disorder
Zevaskyn is the first and only autologous cell-based gene therapy for recessive dystrophic epidermolysis bullosa ...