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

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 ...

Vaccination not only safeguards the health of individuals but also preserves the collective health of our communities, ...

GE HealthCare, Siemens Healthineers and Philips are working on generative AI products that aggregate patient data to make ...

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.

The ruling prevents the FDA rule on LDTs, which is opposed by much of the clinical lab industry and many segments of the broader healthcare industry, from going into effect.

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

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

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

Stocks were lower in afternoon trading Monday, extending a three-day-losing streak, as investors await announcements on a new ...

A chicken salad sandwich that is primarily sold in vending machines in two states has been recalled. Also recalled are ...