FDA Related News

Human Drugs

Dupixent sBLA Get Priority Review for COPD

FDA accepts for priority review a Sanofi and Regeneron supplemental BLA for Dupixent (dupilumab) as an add-on maintenance treatment in certain adult p...

Human Drugs

Venatorx/Melinta Antibiotic Gets Complete Response

FDA issues Venatorx Pharmaceuticals and Melinta Therapeutics a complete response letter on their NDA for cefepime-taniborbactam, a beta-lactam/beta-la...

Medical Devices

Bioporto Pediatric Kidney Injury Assay Cleared

FDA clears a Bioporto 510(k) for its ProNephro AKI (NGAL) biomarker assay for detecting pediatric acute kidney injury.

Human Drugs

FDA to Change Some Trial Registration Enforcement

FDA says it has responded to a Universities Allied for Essential Medicines by creating a dashboard of Clinical Trials.gov pre-notice letters on potent...

Medical Devices

ClearPoint Brain Modeling Software Cleared

FDA clears a ClearPoint Neuro 510(k) for use of its ClearPoint 2.2 software with the integrated Maestro Brain Modeling.

Medical Devices

Zimmer Robotic Shoulder System Cleared

FDA clears a Zimmer Biomet 510(k) for the ROSA Shoulder System for robotic-assisted shoulder replacement surgery.

Marketing

Industry Faults FDA Research on DTC Implied Claims

Industry stakeholders question the usefulness and design of proposed CDER Office of Prescription Drug Promotion research into implied claims in direct...

Human Drugs

Nearly 1,000 Generic Drugs OKd in 2023

The CDER Office of Generic Drugs 2023 annual report details the 956 ANDAs approved or tentatively approved last year.

Election Year Will Affect FDA Actions: Attorneys

Two Hogan Lovells attorneys and two Greenleaf Health executives discuss FDA actions in this election year at a recent J.P. Morgan healthcare conferenc...

Medical Devices

Breakthrough Status for Cognitive Behavioral Therapy

FDA grants Better Therapeutics a breakthrough device designation for its Cognitive Behavioral Therapy platform that is intended to treat adults with m...