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 ...

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

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

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

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

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

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

On December 17, 2024, the FDA published five (5) warning letters previously issued to makers of knockoff GLP-1 drugs. Four of the five warning letters were to companies (specifically, Xcel ...

The Federal Drug Administration has issued a warning against the use of over-the ... The FDA also sent a letter to gas ...

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 ...