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

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

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 ...

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 ...

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

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 ...

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 ...

JonesResearch says shares of Capricor Therapeutics (CAPR) saw some volatility over an FDA warning letter issued to an investigator involved in the deramiocel HOPE-3 study, Dr. Phan. After ...