CDRH launches a new Web page to discuss mission-critical priorities of data and technology innovations and provide information and resources on its Di...
FDA approves a Getinge PMA for its iCast covered stent system for treating patients with iliac arterial occlusive disease.
Pharmaceutical Research and Manufacturers of America says a recent FDA draft guidance on oncologic drug development provides limited information on ho...
FDA issues Incyte a complete response letter for Jakafi (ruxolitinib) extended-release tablets, a JAK1/JAK2 inhibitor for once-daily use in treating c...
An FDA advisory committee votes 9 to 0 that Biogens amyotrophic lateral sclerosis drug tofersen should be considered for accelerated approval.
As required by the PDUFA 7 agreement, FDA publishes a framework for how it will implement a multifaceted program for using digital health technologies...
FDA adds the Xtrava Health SPERA Covid-19 test to the list of tests expected to have a reduced performance with certain Covid-19 Omicron sub-variants.
FDA-funded research finds that unibody endografts are not non-inferior to non-unibody devices, leading to updated FDA labeling.
