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

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

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

FDA issues warning to Hologic, citing manufacturing and safety violations for BioZorb devices. Patient safety risks and reporting failures highlighted ...

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

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

A proposed rule would require food manufacturers to put labels on the front of packages flagging levels of salt, added sugar ...

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months ...

The decision marked the second time Barker has blocked the FDA's warning label rule. In 2022, the judge concluded the requirement violated the companies' speech rights under the U.S. Constitution ...

He also said the agency only used the exact text required by law for two out of its 11 warning labels. The FDA recommended new health warnings with color images for cigarette packages and ...

Your food could soon come with a warning label. Under a new rule proposed Tuesday by the Food and Drug Administration, food manufacturers would be required to put new labels on the front of ...

Preliminary Q1’25 organic Breast Health revenues exclude SSI revenues of $0.3 million and Endomagnetics revenue of $14.2 million. Hologic has not yet completed its financial close processes for ...