Latest Fda Regulatory News

INOVIQ Limited reports strong clinical validation for its EXO-OC ovarian cancer screening test and promising preclinical results for CAR-exosome therapeutics targeting aggressive cancers.

Optiscan Imaging Ltd has commenced a landmark clinical study at Royal Melbourne Hospital, testing its cutting-edge InVue® and InForm™ devices to improve breast cancer surgery precision. The study aims to generate critical data for US FDA approval and could redefine surgical oncology workflows.

Optiscan Imaging Ltd has entered a five-year exclusive collaboration with Long Grove Pharmaceuticals to jointly develop new clinical applications for the fluorescein drug AK-FLOUR®, supporting US clinical trials and FDA regulatory submissions for Optiscan’s InVue® surgical device.

4DMedical has renewed and expanded its contract with Stanford University’s 3DQ Lab to include its innovative CT – VQ™ imaging technology ahead of FDA clearance, marking a significant step in its U.S. market expansion.

BlinkLab Limited has raised A$7.66 million through a well-supported placement to accelerate FDA regulatory trials for its autism and ADHD diagnostic platforms, leveraging its innovative smartphone-based technology.

Artrya Limited has secured A$15 million through a two-tranche placement aimed at accelerating regulatory approvals and commercial rollout of its Salix® coronary artery disease diagnostic software in the US.

LTR Pharma reports compelling clinical results for its nasal spray ED treatment SPONTAN®, demonstrating rapid absorption and strong safety, alongside strategic partnerships and a robust $34 million cash position.

CurveBeam AI has reported a record quarter for HiRise™ device purchase orders, driven by a strategic expansion with Stryker in Australia and New Zealand. The company also advanced its FDA regulatory pathway for its BMD module, setting sights on mid-2025 submission.

Zelira Therapeutics has received a fourth funding tranche, bringing total investment to US$3.25 million to support FDA clinical trials of its HOPE® 1 cannabinoid medicine targeting irritability in autism spectrum disorder and Phelan-McDermid Syndrome.

Respiri Limited reports a standout December quarter marked by a 67% surge in patient program enrolments and robust revenue growth, bolstered by strategic acquisition synergies from Orb Health. The company is poised for further expansion in 2025 amid promising contract negotiations and evolving US healthcare reimbursement policies.