Martin Makary, commissioner of the Food and Drug Administration, on the push against ultra processed foods and added sugar, ...

Clinical and commercial quality controls are eased as the FDA looks to expedite therapy approvals in areas of unmet need.

The Food and Drug Administration (FDA) has upgraded a nationwide cheese recall affecting products sold at major retailers, ...

The FDA announced that a recall of cheese products has been upgraded to the most serious risk category after testing positive ...

The FDA has issued a second complete response letter to Atara Biotherapeutics for its biologicals license application of ...

The FDA has updated guidance outlining how it applies regulatory flexibility to chemistry, manufacturing and control requirements for cell and gene therapies. The agency said the approach is meant to ...

FDA Commissioner Marty Makary called these changes “common-sense reforms” that could expedite the development of cell and ...

The reclassification is tied to the detection of Listeria monocytogenes, a bacteria that can cause severe illness.

Three key themes emerged across the mifepristone documents: consistent safety findings, lack of ideological bias in staff ...

Atara Biotherapeutics received a second complete response letter from the FDA for its biologics license application for ...

The FDA’s Office of Prescription Drug Promotion asserted that BeOne’s Teams backgrounds made benefit claims without providing ...

The U.S. Food and Drug Administration on Monday declined to approve Atara Biotherapeutics' cell therapy for a rare form of ...