FDA clears a CardioNXT 510(k) for its heart treatment delivery platform.
The Natural Products Association asks FDA to declare N-acetyl-L-cysteine a legal dietary supplement ingredient.
AdvaMed provides comments in three categories on a CDRH discussion paper on a framework for conveying materials information to patients healthcare pro...
FDA grants GlaxoSmithKline an accelerated approval for Jemperli (dostarlimab-gxly) for adult patients with mismatch repair deficient recurrent or adva...
Attorney Andrew Tauber says two appeals court decisions in the last three years have strengthened implied preemption of state law drug cases.
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...
FDA approves Boehringer Ingelheim and Eli Lillys diabetes drug Jardiance (empagliflozin) 10 mg for reducing the risk of cardiovascular death plus hosp...
FDA issues a letter to healthcare providers warning them to stop using and discard all ultrasound gels and lotions manufactured by Eco-Med Pharmaceuti...