The Food and Drug Administration is investigating a new outbreak of infections caused by Listeria monocytogenes. There are 28 ...

A federal report found the FDA is struggling to meet inspection targets at high-risk facilities. We look at why these checks ...

Dexcom was issued with an FDA warning letter after issues with “manufacturing processes and quality management systems.” ...

DexCom received a warning letter from the Food and Drug Administration following inspections of its San Diego and Mesa, Ariz.

Dexcom announced today that it received a warning letter from the FDA following inspections of two company facilities.

If drug tariffs don’t work, they could result in higher prices for American patients and increase drug shortages. Testing ...

The company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek ...

Pharmaceutical company Alkem Laboratories Ltd on Thursday (March 13) announced that the United States Food and Drug ...

Dexcom has received a warning letter from the FDA, after the agency uncovered issues during two inspections of the continuous ...

FDA staffers tell CR how the suspension of their discretionary spending is threatening the safety of the American food supply ...

DexCom received a warning letter from the Food and Drug Administration following inspections of two of its plants.