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

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

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 ...

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

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

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

Product approvals in regenerative medicine and rare diseases are among the highlights in our recap of recent FDA regulatory ...

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

Fagron (ARSUF) has refocused its M&A strategy, regaining market trust despite recent FDA issues. Read why I think the stock ...

The UK-based firm has issued five Class II recalls for its RX-series analyzers since 2018 for issues related to reagent carryover between subsequent tests.

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 ...