James Jones resigned as FDA deputy commissioner and said the Trump administration's "indiscriminate" job cuts show "disdain for the very people necessary to implement your agenda." ...

FDA complete response letters detail application flaws and data issues, guiding drug approvals. These letters help investors predict drug approval timelines and potential market entries.

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

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

Jim Jones, director of the Food and Drug Administration’s food division, slammed the “indiscriminate firing” of dozens of his employees and recent rhetoric from Health and Human Services Secretary ...

The company said the letter from the Food and Drug Administration (FDA) noted "deficiencies in the response" from DexCom to ...

The FDA will explore potential rulemaking to revise its Substances Generally Recognized as Safe (GRAS) Final Rule and related ...

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

Medical device maker Dexcom said it has received a warning letter from the U.S. Food and Drug Administration following ...

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...

In a regulatory filing, DexCom (DXCM) disclosed that on March 4, the company received a warning letter from the U.S. FDA following inspections ...