FDA News Briefs

These Food and Drug Administration (FDA) approvals were recently announced:Nulibry (fosdenopterin)On February 26, 2021, the FDA approved a new drug application for Nulibry (fosdenopterin; Origin Biosciences Inc.) to reduce the risk of of mortality in patients with...

FDA Safety Alert: Medtronic HVAD Pump Implant Kits

The Food and Drug Administration (FDA) has announced a recall of specific lots of the Medtronic HVAD pump implant kits due to a possible delay or failure to start. The HeartWare Ventricular Assist Device (HVAD) pump implant kit is part of the HeartWare HVAD System,...

FDA Issues EUA for Third COVID-19 Vaccine

The Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the Janssen COVID-19 vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for use in...