FDA approves Terumo BCTs sodium citrate 4% solution USP, indicated for anticoagulating whole blood during automated apheresis procedures.
FDA places a clinical hold on a Mersana Therapeutics Phase 1 study of XMT-1522 after the company reported a Grade 5 Serious Adverse Event (patient dea...
CDER professional affairs and stakeholder engagement director John Whyte leaves the agency for WebMD.
FDA approves Novartis Kisqali for a new breast cancer indication using a pilot oncology review program to make the process more efficient and timely.
Federal Register notice: FDA makes available a draft guidance entitled Metal Expandable Biliary Stents Premarket Notification (510(k)) Submissions....
FDA publishes an International Conference on Harmonization guidance on planning and designing multiregional clinical trials.
FDA publishes a draft guidance with questions and answers on requirements for NDA and ANDA applicants to submit field alert reports under specific con...
FDA clears an Adaptiiv 510(k) for its 3D Bolus Software for use in creating customized personal medical devices using 3D printing, primarily for use i...