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 ...

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 ...

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

Hologic: Continued Room Amidst Bolt-On M&A Efforts Hologic GAAP EPS of $1.01 beats by $0.18, revenue of $987.9M beats by $11.21M Hologic Q3 2024 Earnings Preview Seeking Alpha’s Quant Rating on ...

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 ...