FDA warns two breast implant manufacturers about deficiencies in their mandated post-approval studies of device long-term safety and risks.
FDA places a partial clinical hold on an AbbVie and Roche clinical trial program for Venclexta/Venclyxto (venetoclax) for the investigational treatmen...
FDA sends a Warning Letter to Nutra Pharma for illegally marketing unapproved products labeled as homeopathic with claims for treating addiction and c...
Mylan recalls two lots of levoleucovorin injection, 250 mg/25 mL due to the presence of particulate matter that has been identified as copper salts.
FDA approves a Genentech sBLA for Tecentriq (atezolizumab) for combination use with carboplatin and etoposide for first-line treatment of adults with ...
FDA warns TEI Biosciences about Quality System violations in its manufacturing of collagen-based medical devices.
FDA warns United Exchange about CGMP violations at two facilities producing finished pharmaceuticals.
Two stakeholders request changes to an FDA draft guidance on the content of premarket submissions for managing medical device cybersecurity.