Harvard University researchers say drug regulators must balance incentives for expedited approvals of first-in-class drugs with evidence supporting ef...
FDA grants Nurix Therapeutics an orphan drug designation for bexobrutideg and its use in treating Waldenstrm macroglobulinemia.
FDA warns Adventura, FL-based Mehran Bahrami about objectionable conditions in his conduct of three clinical investigations.
FDA warns Elmsford, NY-based Advanced Pharmaceutical Technology about repeat CGMP regulation violations in its production of combination drug-device p...
FDA posts its concerns with unapproved GLP-1 drugs used for weight loss.
FDA clears a Moon Surgical 510(k) for its ScoPilot, an artificial intelligence-powered feature on the companys Maestro System intended to ensure a sta...
FDA grants Johnson & Johnson a fast track designation for its investigational therapy, nipocalimab and its use for treating adult patients with Sjgren...
Medtronic Neurovascular recalls its Compatible Pipeline Vantage Embolization (027) Devices and updating the use instructions for their 021 version due...
