CDER first-cycle drug approvals last year shot up to 84% (46 of 55 NDAs) from 76% (28 of 37 NDAs) in 2022, according to a just-released approvals repo...
FDA endorses vaporized hydrogen peroxide to be an established sterilization method for medical devices.
Federal Register notice: FDA seeks comments on an information collection extension entitled Expedited Programs for Serious Conditions Drugs and Biolo...
Megadyne Medical Product recalls its Mega Soft Universal Patient Return Electrodes to update its Instructions for Use and product labeling.
FDA grants Cabaletta Bio a fast track designation for CABA-201, an investigational 4-1BB-containing CD19-CAR T cell therapy.
Endotronix files a PMA for the Cordella Pulmonary Artery (PA) Sensor System, a heart failure patient management platform for home monitoring.
Insulet Corp. recalls its Omnipod 5 smartphone application and software that is used to control an insulin pump due to an error in the bolus calculato...
