Three developers of the Intarcia Therapeutics ITCA 650 drug-device implantable product to improve glycemic control accuse CDER officials of making err...
FDA publishes a draft guidance describing its process for requesting and conducting voluntary remote interactive evaluations of some drug and bioresea...
FDA approves Medinols EluNIR-PERL drug-eluting stent for treating coronary artery disease.
FDA clears a Denti.AI 510(k) for its Denti.AI Detect, which is described as a state-of-the-art imaging solution engineered to aid dental professionals...
Florida officials ask a federal court to give FDA a bit longer to decide whether to approve a state plan to import some drugs from Canada for use in g...
FDA accepts for review an Akebia Therapeutics NDA resubmission for vadadustat for treating anemia due to chronic kidney disease in adult patients on d...
BioXcel Therapeutics says an independent data integrity audit of a TRANQUILITY II clinical trial site that was the subject of an FDA form FDA-483 repo...
FDA commissioner Robert Califf posts a positive report on his recent visit to India and the work he says that the countrys government and drug industr...
