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CardioNXT Heart Treatment Navigation System Cleared

[ Price : $8.95]

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

Petition Wants NAC Declared Legal Dietary Ingredient

[ Price : $8.95]

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

AdvaMed Comments on CDRH Discussion Paper

[ Price : $8.95]

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

FDA Grants Covis Hearing Request on Makena

[ Price : $8.95]

FDA approves a Covis Pharma request for a hearing on CDERs proposal to withdraw approval for Makena.

Sponsored Links Misbrand Eton Alkindi Sprinkle: OPDP

[ Price : $8.95]

The CDER Office of Prescription Drug Promotion cautions Eton that online sponsored links for its Alkindi Sprinkle dont contain any...

GSK Accelerated Approval for Tumor Drug Jemperli

[ Price : $8.95]

FDA grants GlaxoSmithKline an accelerated approval for Jemperli (dostarlimab-gxly) for adult patients with mismatch repair deficie...

Courts Strengthen Implied Preemption of Drug Changes

[ Price : $8.95]

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

FDA Pediatric ECG Warehouse Helps Product Development

[ Price : $8.95]

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

FDA Approves Jardiance for Heart Failure

[ Price : $8.95]

FDA approves Boehringer Ingelheim and Eli Lillys diabetes drug Jardiance (empagliflozin) 10 mg for reducing the risk of cardiovasc...

FDA Warning on All Eco-Med Ultrasound Gels

[ Price : $8.95]

FDA issues a letter to healthcare providers warning them to stop using and discard all ultrasound gels and lotions manufactured by...