Apple’s earbuds and smartwatches are taking on medical-grade features, from hearing support to sleep apnea detection.

A recall of thousands of cases of fruits and vegetables has been issued due to potential fluid contamination—the ...

A Kansas City company is illegally marketing pills that have opioid-like effects and could face possible action, the U.S. Food and Drug Administration wrote in a warning letter sent Tuesday.

Ultragenyx received a Complete Response Letter from the FDA for UX111 AAV gene therapy to treat Sanfilippo Syndrome Type A ...

We relish these fruits, vegetables, and herbs during summer, but consumers should know about contamination concerns tied to ...

The FDA’s decision to clear the Apple Watch is a big deal because it shows they are open to new kinds of medical devices. It ...

HHS Secretary Robert F. Kennedy Jr. asked the FDA "to review the latest data on mifepristone ," but experts say concerns about the abortion pill's safety are misguided.

FDA rushed out agency-wide AI tool—it’s not going well An agency-wide LLM called Elsa was released weeks ahead of schedule.

The Food and Drug Administration on Thursday announced an aggressive agency-wide Artificial intelligence adoption timeline that includes an AI-assisted scientific review pilot.

The FDA plans to limit access to certain high-risk groups and also told Pfizer and Moderna to update their warning labels about heart inflammation.

The FDA’s recent activities regarding Covid-19 vaccines stray far from the well-established standards of vaccine regulatory processes.