FDA warns Surgisil it is manufacturing unapproved medical devices and is making misleading statements about agency approval in its promotional materia...
FDA warns Newton Laboratories about multiple violations involving finished pharmaceuticals and unapproved animal drugs.
FDA says user error has caused excess radiation exposure to patients undergoing PET myocardial perfusion imaging with certain systems used to produce ...
FDA clears a VivaQuant 510(k) for its RX-1 wearable device, which is intended to continuously monitor a patients ECG and identify arrhythmias.
FDA approves a Vertex Pharmaceuticals supplemental NDA for Kalydeco (ivacaftor) to expand its use in children with cystic fibrosis (XXX DELETE XXX) ag...
FDA approves an AbbVie supplemental NDA for Mavyret (glecaprevir and pibrentasvir) tablets to expand treatment in all six genotypes of hepatitis C vir...
FDA approves Becton Dickinsons BD ChloraPrep skin preparation with sterile solution, a chlorhexidine gluconate antiseptic.
FDA adds a Boxed Warning and Contraindication to labeling for several prescription insomnia drugs about rare but serious injuries associated with comp...