In a filing made public on Saturday, the company said the inspection concluded with the U.S. regulator issuing Form 483, ...

On conclusion of the inspection, the company received one observation in the Form-483. The company believes that the observation is procedural in nature. The company is confident to address this ...

Capricor Therapeutics' rating was downgraded amid FDA inspection risks, regulatory uncertainty, and potential delays in ...

Capricor Therapeutics shares dropped after the U.S. FDA inspected its San Diego manufacturing facility. Read more here.

U.S. FDA successfully completed Pre-License Inspection; Company expects facility will meet all requirements to support licensure Advisory Committee meeting scheduled for July 30, 2025 Mid-cycle ...

The agency has provided only limited details about its AI pilot as it advances an “aggressive timeline” for the tool's ...

The FDA introduced Elsa, an artificial intelligence (AI) tool intended to enhance efficiency in clinical reviews and ...

This site displays a prototype of a “Web 2.0” version of the daily Federal Register. It is not an official legal edition of the Federal Register, and does not replace the official print version or the ...

Last month, Soldner took the Trump administration up on its offer of early retirement, joining an exodus from the Food Safety and Inspection ... the Food and Drug Administration, the Department ...

BOSTON, May 29, 2025 /PRNewswire/ -- On May 20, Medicilon Preclinical Research (Shanghai) LLC ("Medicilon") announces that it has successfully passed an on-site inspection by the FDA. The company ...