FDA says it cant approve a Medexus NDA for treosulfan in its present form.
FDA clears a Camber Spine 510(k) for both its Spira-P Posterior Lumbar Spacer technology and Spira-T Oblique Posterior Lumbar Spacer technologies.
The Rare Disease Company Coalition calls on House and Senate leaders to strengthen the FDA accelerated approval pathway and block payment and coverage...
BD says it will start remediation of a 2020 recall of its Alaris infusion pump system with a new software version.
Federal Register notice: FDA updates its listing of Emergency Use Authorizations (EUAs) for use during the COVID-19 pandemic to reflect recent EUAs gr...
Federal Register notice: FDA determines that Novartis Votrient (pazopanib hydrochloride) tablets, 400 mg, were not withdrawn from sale due to safety o...
Federal Register notice: FDA extends the comment period for a 6/24 notice on a draft guidance entitled Remanufacturing of Medical Devices.
FDA says it has joined several additional medical device collaborative communities.