Ocular Therapeutix resubmits its NDA for Dextenza (dexamethasone insert) 0.4mg, indicated for treating ocular pain following ophthalmic surgery.
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Federal Register notice: FDA makes available a draft guidance entitled Metal Expandable Biliary Stents Premarket Notification (510(k)) Submissions....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FDA publishes a draft guidance with questions and answers on requirements for NDA and ANDA applicants to submit field alert reports under specific con...