FDA clears a Nanowear 510(k) for its SimplECG, a remote cardiac monitoring undergarment.
Federal Register Notice: FDA posts a draft guidance on Physiologically Based Pharmacokinetic Analyses Format and Content.
FDA says Medtronic has recalled four neurovascular products due to the risk of coating separation and detachment.
After a 392-26 passage in the House, the 21st Century Cures Act heads to the Senate and could see a vote as early as next week.
FDA accepts for priority review a Merck supplemental BLA for Keytruda (pembrolizumab), an anti-PD-1 therapy for treating patients with refractory clas...
FDA clears a BrightWater Medical 510(k) for the ConvertX Nephroureteral Stent System for treating ureteral obstructions, which prevent urine in the ki...
FDA updates six REMS, including approval of a REMS for Novo Nordisks Xultophy.
Two Project on Government Oversight reports call for an end to user fees that the group says make FDA too financially dependent on regulated industry.