Latest Fda News

Mesoblast has raised A$260 million through a global private placement to fund the US commercial launch of its FDA-approved cell therapy Ryoncil® and accelerate clinical development in chronic low back pain.

Telix Pharmaceuticals has exceeded its full-year 2024 revenue guidance, driven by strong sales of its prostate cancer diagnostic Illuccix® and strategic pipeline advancements.

4DMedical has landed a paid pilot contract with the US Department of Defense to deploy its CT:VQ™ lung imaging technology on active-duty personnel, marking a significant step before FDA submission and spotlighting a billion-dollar market opportunity.

EBR Systems has announced a rescheduling of the FDA Pre-Approval Inspection for its wireless cardiac pacing device to January 14, 2025, while maintaining its regulatory approval timeline for Q1 2025 and a commercial launch later in the year.

EBR Systems Inc. has responded to ASX's price query, denying any undisclosed information behind recent trading spikes and confirming compliance with listing rules. The company also flagged an upcoming FDA inspection announcement.