FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

bioMrieux Gets Vitek Compact Pro Cleared

[ Price : $8.95]

FDA clears a bioMrieux 510(k) for the latest version of its Vitek Compact Pro for microorganism identification and antibiotic susc...

Sarepta Reports Death Linked to Elevidys

[ Price : $8.95]

Sarepta says a young man with Duchenne muscular dystrophy being treated with Elevidys has died from acute liver failure.

Balance Drug Approval Flexibility, Evidence: Study

[ Price : $8.95]

Harvard University researchers say drug regulators must balance incentives for expedited approvals of first-in-class drugs with ev...

Nurix Gets Orphan Status for Bexobrutideg

[ Price : $8.95]

FDA grants Nurix Therapeutics an orphan drug designation for bexobrutideg and its use in treating Waldenstrm macroglobulinemia.

Physician-Investigator Objectionable Conditions

[ Price : $8.95]

FDA warns Adventura, FL-based Mehran Bahrami about objectionable conditions in his conduct of three clinical investigations.

Advanced Pharmaceutical Repeat CGMP Violations

[ Price : $8.95]

FDA warns Elmsford, NY-based Advanced Pharmaceutical Technology about repeat CGMP regulation violations in its production of combi...

FDA Outlines Concerns with Unapproved GLP-1 Drugs

[ Price : $8.95]

FDA posts its concerns with unapproved GLP-1 drugs used for weight loss.

Moon Surgicals AI-enabled ScoPilot Cleared

[ Price : $8.95]

FDA clears a Moon Surgical 510(k) for its ScoPilot, an artificial intelligence-powered feature on the companys Maestro System inte...

J&J Gets Fast Track for Sjgrens Drug

[ Price : $8.95]

FDA grants Johnson & Johnson a fast track designation for its investigational therapy, nipocalimab and its use for treating adult ...

Medtronic Recalls Vantage Embolization Devices

[ Price : $8.95]

Medtronic Neurovascular recalls its Compatible Pipeline Vantage Embolization (027) Devices and updating the use instructions for t...