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...
FDA adds Bulgaria and Cyprus to the list of European Commission member countries participating in a mutual recognition agreement for CGMP inspections ...
FDA releases its latest batch of Warning Letters that includes Newton Laboratories and Surgisil.
Federal Register notice: FDA submits to OMB an information collection extension for Public Health Service Guideline on Infectious Disease Issues in Xe...
Edwards Lifesciences recalls its Miller Balloon Atrioseptostomy Catheter and Fogarty Dilation Atrioseptostomy Catheter due to difficulty in balloon de...