A recall of seafood burgers by the Connecticut based company Caraluzzi's Markets has been issued a Class I risk ...

(Reuters) -Neuralink has received the U.S. Food and Drug Administration's "breakthrough" tag for its device to restore ...

The Food and Drug Administration is again trying to rehire some staffers who were recently fired amid mass layoffs at the ...

In an exclusive interview with physician and writer Dr. Jeremy Faust on Substack, Makary opened up about his first weeks on ...

Zevaskyn is the first and only autologous cell-based gene therapy for recessive dystrophic epidermolysis bullosa ...

Dr. Marty Makary, chief of the FDA, has expressed doubts about the agency approving the COVID-19 vaccine for winter, stating ...

Several current and former FDA employees who spoke to Inside Medicine on the condition of anonymity have come to see the ...

The head of the Food and Drug Administration said Tuesday that the agency is now looking at whether it will still approve ...

The FDA approved nipocalimab (Imaavy) injection to treat adults and children ages 12 and older with generalized myasthenia ...

There’s new uncertainty about updated COVID-19 shots this fall after the Trump administration’s handling of a shot from ...

Multiple current and laid-off FDA employees said the abrupt layoffs had resulted in delays and disruptions to the agency's ...

A new drug application seeking the approval of ziftomenib was submitted to the FDA on April 8, 2025. This indication is for ...