Latest Fda News

Dimerix has reached a key milestone by enrolling the first paediatric patient aged 12-17 in its ACTION3 Phase 3 trial for DMX-200, advancing its potential treatment for childhood FSGS kidney disease.

Orthocell Limited has reported a third consecutive quarter of record revenue, driven by strong sales growth and strategic market expansions, including a key US FDA submission for its nerve repair product Remplir™.

Immuron has submitted its Phase 2 clinical study report for Travelan® to the FDA, revealing statistically significant immunological and microbiome benefits. The company is preparing to engage the FDA for Phase 3 trial discussions while progressing a large field study with military personnel.

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.