News

FDA to rehire fired staffers who booked inspection trips, but other workers remain in limbo
For the second time in recent months, the Food and Drug Administration is bringing back some recently fired employees, ...
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 ...
Candy Recall Update as FDA Sets Risk Level
Milk not declared as an allergen was found in a Tennessee-based manufacturer's confectionery, not the first time candy has been recalled in the U.S. in 2025.
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 ...
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 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 ...
Fierce Pharma21h
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 ...
STAT2d
Will the FDA approve the first new drug to help people quit smoking in 20 years?
The drug cytisinicline could help expand options for quitting smoking, and if approved by the FDA, would be the first new ...
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 Chief Says He Won’t Reorganize Agency After Mass Layoffs (1)
The FDA doesn’t plan to execute a reorganization of the agency but will consolidate offices that handle travel, technology, ...
FDA Approves Zevaskyn for Rare, Genetic Skin Disorder
Zevaskyn is the first and only autologous cell-based gene therapy for recessive dystrophic epidermolysis bullosa ...
Bread Recalled Over 'Glass Fragments' as FDA Warns Consumption Could Cause 'Adverse Health Consequences'
Bread and rolls sold in six states have been recalled over 'glass fragments,' according to the U.S. Food and Drug ...