On March 31, a judge in the Eastern District of Texas vacated the US Food and Drug Administration’s (FDA) rule that sought to ...

Artificial intelligence has become one of the most transformative forces in health care, reshaping everything from drug discovery to diagnostics.

A federal judge in Texas has ruled that the FDA does not have the authority to regulate laboratory developed tests as medical ...

U.S. Food and Drug Administration approvals of life-changing, high-risk medical devices reportedly slowed to a 10-year low ...

A federal judge in Texas has blocked the FDA’s plans to bring laboratory-developed tests under the same regulations it uses ...

Less regulation was also the focus of committee chair Rep. James Comer (R-Ky.). "The Biden administration stifled innovation ...

A Texas judge vacated the FDA’s final rule, which was strongly opposed by the laboratory industry, and remanded the matter to ...

Massive workforce cuts at the Food and Drug Administration could hinder the agency's critical work involving medical device ...

Teams working on device communications and policy were cut from the agency on Tuesday, according to multiple FDA workers.

The Food and Drug Administration has gutted a division responsible for training agency staff and outside health-care ...