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

Hologic received a warning letter in December from the Food and Drug Administration related to safety concerns with the company’s Biozorb implantable radiographic markers. The FDA found that ...

Hologic Inc. has received a warning letter from the Food and Drug Administration regarding its BioZorb product line, even though the company recalled the devices last year. Hologic Inc. has ...

The U.S. Food and Drug Administration has sent a warning letter to Marlborough, Mass.-based medical technology company Hologic Inc. over concerns it hasn't done enough to prevent harm from a ...

Get Pro-Level Earnings Insights Before the Market Moves The letter ... Also Read: Hologic Recalls Soft Tissue Marker Device BioZorb, FDA Issues Warning After Almost 400 Complaints Key violations ...

The warning letter follows an FDA inspection of Hologic’s Marlborough, Massachusetts, headquarters between July 30, 2024, and Sept. 24, 2024. The FDA raised concerns that Biozorb’s device design did ...

French pharmaceutical giant Sanofi has received a warning letter from the U.S. Food and Drug Administration following an inspection at its drug manufacturing facility in Framingham.

Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 Warning Letter 1 from the US Food and Drug Administration ...

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 Wichita facility has been in the news recently, as the company received a warning letter from the FDA after an inspection that was conducted in June of last year. According to Fagron ...