The U.S. Food and Drug Administration's chief counsel, Hilary Perkins, has resigned, the federal agency said in a post on ...

It’s time to revamp the FDA’s “generally recognized as safe,” or GRAS, program that allows companies to add untested ...

Four Oxford Center employees, including the CEO and safety manager, have been charged in connection to the death of a ...

Magellan Diagnostics’ former CEO Amy Winslow pleaded guilty on 11 March to concealing device malfunctions in the company’s LeadCare lead detection tests that led to inaccurately low blood lead level ...

Two recent documents—one from the FDA, the other from a commission organized by The Lancet Diabetes & Endocrinology—indicate ...

The software can determine the extent and severity of coronary plaque build-up implicated in coronary artery disease.

The FDA has declared the shortages as “resolved ... demand for the compounded versions of the drug,” Scott Brunner, CEO of Alliance for Pharmacy Compounding, another compounding industry ...

Fred Aslan, MD, CEO, Artiva Biotherapeutics, explains what the FDA Fast Track designation for AlloNK in autoimmune diseases means for the acceleration of its development and potential approval of the ...

Doron Therapeutics, a clinical-stage biotechnology company based in Chapel Hill, has received a Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration ...