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 ...

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

The company cannot give any assurances that the FDA will be satisfied with the company’s response or as to the expected date of the resolution of the matters included in the warning letter.

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