FDA issues Merck a complete response letter on a supplemental BLA seeking to update the dosing frequency for Keytruda (pembrolizumab) to include a 400...
ResMed recalls its Stellar 100 and 150 Non-invasive and Invasive Ventilators due to a sound alarm failure.
FDA issues an Establishment Inspection Report to Aurobindo Pharma for its Pashamylaram Unit 4 injectable manufacturing facility.
Office of Generic Drugs director Sally Choe says more than 1,000 ANDAs were given final or tentative approval in 2019.
FDA says an Abbott Vascular recall of specific lots of coronary dilation catheters due to a balloon issue is Class 1.
Reps. McCarthy and Schweikert encourage FDA to schedule public workshops on Valley Fever therapies and use the lessons learned to develop a guidance f...
FDA extends for three months the PDUFA goal date for a Heron Therapeutics NDA for an extended-release local anesthetic.
An appeals court has sent back to a federal district court an antitrust case involving the Sanofi Lantus SoloStar insulin device in which purchasers s...