Democratic senators are expressing alarm about planned budget reallocations at the Food and Drug Administration that they fear will threaten ...

There were unforgiveable shortcomings in management, which included critical information not reaching senior officials as ...

The FDA issued a warning letter to ProRx, a compounding facility in Exton, Penn., after an inspection raised serious concerns regarding the safety and compliance of its drug products. The facility, ...

Food safety experts explain why there have been so many food recalls lately, plus how to stay on top of the latest news ...

In response to a report from the Government Accountability Office, the FDA says the biggest stumbling block to conducting inspections of food facilities ...

The FDA issued a warning letter to Sanofi regarding significant manufacturing violations at its Genzyme Corporation Facility in Framingham, Mass. The letter, dated Dec. 16, 2024, and amended Jan. 15, ...

Lab-developed tests (LDTs) are laboratory tests where blood is drawn and placed in a test tube to help with identification, diagnosis, and ...

After receiving a complete response letter last week, the other shoe has dropped for Atara Biotherapeutics and its pipeline ...