Latest Fda Approval News

PolyNovo Limited reports a robust 22.8% revenue increase in 1H FY25, driven by strong U.S. and international sales growth and progressing FDA approval efforts for its NovoSorb platform.

Visioneering Technologies reports promising interim results from its PROTECT trial, showing significant control of myopia progression in children using NaturalVue® Multifocal lenses.

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™.

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.