News

Neuralink's speech restoration device gets FDA's 'breakthrough' tag
(Reuters) -Neuralink has received the U.S. Food and Drug Administration's "breakthrough" tag for its device to restore ...
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 ...
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 ...
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Inside the FDA: Low Morale and Uncertainty Plague Staff
Several current and former FDA employees who spoke to Inside Medicine on the condition of anonymity have come to see 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 ...
Ask a health professional: What does the FDA’s food dye phase-out mean for families?
New FDA regulations are changing what’s allowed in popular snacks and cereals. Here’s what families should know about ...
US FDA chief says firings won't hinder agency's target dates for drug reviews
The U.S. Food and Drug Administration will meet its targets for completing reviews of new drugs despite mass firings at the ...
FDA Approves Zevaskyn for Rare, Genetic Skin Disorder
Zevaskyn is the first and only autologous cell-based gene therapy for recessive dystrophic epidermolysis bullosa ...
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 ...
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A Conversation With FDA Commissioner Marty Makary
Among other things, Makary breaks some news here by stating, for the first time, that there will be no significant ...
FDA scrutiny of Novavax COVID-19 vaccine sparks uncertainty about other shots
There’s new uncertainty about updated COVID-19 shots this fall after the Trump administration’s handling of a shot from ...
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 ...