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

Published in 2024, the FDA’s ‘Final Rule’ outlined plans to subject lab-developed tests to the same requirements as medical ...

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

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

The FDA has long believed it has the power to regulate lab-developed tests, but it only put out the rules under former President Biden.

Sweeping cuts to federal health agencies have created uncertainty about the future of a variety of public health programs.

Fresh Creative Foods has recalled a popular sauce distributed to Trader Joe's stores over undeclared nuts.

A federal judge ruled Monday that the FDA doesn’t have the legal authority to regulate lab-developed tests, dealing a blow to ...

Trader Joe’s Hot Honey Mustard Dressing has been recalled from stores in 17 states and the District of Columbia, but there ...

Four bills at the center of Monday's public hearing target how vaping products are marketed to minors and clarify which ...

Treatment with tovecimig, formerly known as CTX-009, elicited responses in patients with biliary tract cancer, according to ...

The FDA overstepped its authority when it issued a rule last May to bring laboratory-developed tests under the agency’s ...