The U.S. Food and Drug Administration has sent a warning letter to Marlborough, Mass.-based medical technology company ...

Last year ended with warnings about malicious websites parting holiday shoppers with their hard earned cash, and 2025 has ...

Hologic stopped manufacturing the device after reports of serious adverse events in patients who had the markers implanted in breast tissue.

Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 ...

U.S. regulators on Wednesday banned the dye called Red 3 from the nation's food supply, nearly 35 years after it was barred ...

Hologic Inc. has received a warning letter from the Food and Drug Administration regarding its BioZorb product line, even ...

The UK-based firm has issued five Class II recalls for its RX-series analyzers since 2018 for issues related to reagent carryover between subsequent tests.

The rate of warnings initiated by the FDA continues to rise in the pharma and medical device industries. Knowing how to best ...

Commissioner Robert Califf, M.D., and other senior FDA officials recently published a “Special Communication” in JAMA describing FDA’s concerns with the use of AI in medical product development, ...

A federal judge in Texas has blocked the U.S. Food and Drug Administration from enforcing a looming requirement that ...

As certain weight-loss drugs have become increasingly popular, scammers are taking notice and coming out of the woodwork to ...

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...