FDA Related News

Human Drugs

FDA Fast Track Designation for Senhwas Silmitasertib

FDA grants fast track designation to Senhwa Biosciences silmitasertib for treating recurrent sonic hedgehog medulloblastoma.

Medical Devices

FDA Clears Qure.ai qER-Quant for Brain CT Scans

FDA clears a Qure.ai brain imaging quantification product.

Drug, Device Recalls Continue to Go Down: Sedgwick

The Sedgwick recall index says both medical device and pharmaceutical recalls continued to drop in the second quarter of 2021, hitting new lows.

Medical Devices

FDA Clears Zimmer Biomet Rosa Hip

FDA clears a Zimmer Biomet 510(k) for its Rosa Hip System for robotically-assisted direct anterior total hip replacement.

Medical Devices

CardioNXT Heart Treatment Navigation System Cleared

FDA clears a CardioNXT 510(k) for its heart treatment delivery platform.

Human Drugs

Petition Wants NAC Declared Legal Dietary Ingredient

The Natural Products Association asks FDA to declare N-acetyl-L-cysteine a legal dietary supplement ingredient.

Medical Devices

AdvaMed Comments on CDRH Discussion Paper

AdvaMed provides comments in three categories on a CDRH discussion paper on a framework for conveying materials information to patients healthcare pro...

Human Drugs

GSK Accelerated Approval for Tumor Drug Jemperli

FDA grants GlaxoSmithKline an accelerated approval for Jemperli (dostarlimab-gxly) for adult patients with mismatch repair deficient recurrent or adva...

Human Drugs

Courts Strengthen Implied Preemption of Drug Changes

Attorney Andrew Tauber says two appeals court decisions in the last three years have strengthened implied preemption of state law drug cases.

Human Drugs

FDA Pediatric ECG Warehouse Helps Product Development

FDA says a new pediatric electrocardiogram data warehouse already has almost 40,000 reports to be used in assessing cardiac risk to children through c...