Two top clinicians have been disciplined amid growing concern that Kaiser’s system for monitoring research safety and ethics ...

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

WASHINGTON — The Food and Drug Administration (FDA) has fallen short of its facility inspection targets, according to the ...

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, ...

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

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

Despite receiving a prior wrist slap from the FDA in the shape of a Form 483, Sanofi is still working to right the ship at a ...

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

Aurobindo Pharma's shares drop over 3% after FDA inspection results in VAI classification for subsidiary's API plant.

The U.S. Food and Drug Administration (“FDA”), in partnership with the Department of Justice (“DOJ”), pursued significant and, in some ...