FDA grants Soligenix an orphan drug designation for the active ingredient in MarVax vaccine against MARV infection.
FDA places a clinical hold on a Neumora Therapeutics Phase 1 clinical trial for NMRA-266 for treating brain diseases.
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.
