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 ...

Personalis, Inc. , a leader in advanced genomics for precision oncology, today reported unaudited preliminary revenue for the fourth quarter and full year ended December 31, 2024 and preliminary cash ...

In a warning letter posted online late last month, the FDA scolded Viatris over a range of production slights at the ...

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

Integra Lifesciences recently received an FDA warning letter pertaining to quality systems issues at several facilities.

In a regulatory filing on Monday, Integra LifeSciences (IART) said that on December 19, 2024, a subsidiary received a warning letter from the ...

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

In a regulatory filing on Monday, Integra LifeSciences (IART) said that on December 19, 2024, a subsidiary received a warning letter from the U.S. FDA. The warning letter relates to quality system ...

disclosed Monday that it received a warning letter from the U.S. Food and Drug Administration (FDA) on December 19, 2024, concerning quality system issues at three of its facilities. The company's ...