Abbotts Thoratec unit recalls its HeartMate II and HeartMate 3 Left Ventricular Assist System due to an issue called extrinsic outflow graft obstructi...
CDER announces the launch of its Center for Clinical Trial Innovation, which will focus on promoting clinical trial innovation activities through enha...
Fresenius Kabi USA recalls (Class 1) its large-volume pump software of the Ivenix Infusion System due to software anomalies that have the potential to...
FDA classifies a December inspection at Sun Pharmaceutical Industries Dadra, India facility as official action indicated.
FDAs Oncologic Drugs Advisory Committee unanimously votes (12 to 0) that the totality of data are adequate to support the use of minimal residual dise...
Enlivex Therapeutics reports mixed results from its Phase 2 study of Allocetra in patients with sepsis.
FDA grants PureTech Health a fast-track designation for LYT-200 in combination with anti-PD1 therapy for treating recurrent/metastatic head and neck s...
FDA grants 16 Bit Inc. a de novo marketing authorization for Rho, an AI-enabled software device aimed at improving osteoporosis screening.
