Following Viatris’ December announcement that a manufacturing plant in India had been written up by the FDA, a document published by the U.S. regulator reveals the details behind the company's ...

On December 18, 2025, the Food and Drug Administration (FDA) released a final guidance entitled “Processes and Practices Applicable to Bioresearch Monitoring Inspections.” The guidance was issued to ...

The FDA cracked down on two plants in India and one in Korea in separate recently released reports, citing issues ranging from mold to skirted testing procedures. A Sun Pharma plant in Gujarat, India ...

WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has issued General Correspondence Letters to two third-party testing companies in China after uncovering falsified or otherwise invalid ...

The FDA described Palamur’s responses to these findings as “inadequate’ and started that they “do not provide assurance that ...

Zydus Lifesciences Limited has informed stock exchanges that the United States Food and Drug Administration (USFDA) has ...

Chris is the CTO and Co-Founder of Scientist.com, a Research Platform helping drug discovery researchers develop new therapies. The FDA’s adoption of electronic submissions raised concerns about data ...

NEW HAVEN, Conn., March 03, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in ...

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 ...

MORRISVILLE, N.C., Oct. 08, 2025 (GLOBE NEWSWIRE) -- Science 37, a leader in enhancing patient access to clinical trials, today announced the successful completion of its third FDA inspection, further ...