Latest Regulatory Affairs News

SomnoMed Limited reported a robust FY25 with revenue surpassing guidance and a landmark FDA clearance for its Rest Assure® oral device, setting the stage for sustained growth in oral appliance therapy.

ReNerve Ltd is rapidly advancing its nerve repair product portfolio, with four ranges expected on the market by the end of 2025 and expanding global distribution. Clinical studies highlight significant patient benefits, supporting the company’s growth in a booming biomaterials market.

Cleo Diagnostics reported a $4 million loss for FY2025 while making significant strides toward FDA approval of its novel ovarian cancer blood test. The company is progressing clinical trials and scaling manufacturing in preparation for market entry.

INOVIQ Limited reported a $6.9 million net loss for FY25 while making significant strides in its exosome-based cancer diagnostics and therapeutics pipeline, including a breakthrough ovarian cancer screening test and promising CAR-exosome therapy results.

EVE Health Group has completed its acquisition of Nextract Pty Ltd, positioning itself to enter the lucrative erectile dysfunction and dysmenorrhea markets with innovative drug delivery technologies.

Optiscan Imaging Ltd has revealed its next-generation InForm™ pathology imaging device and strengthened its executive team, while reporting a robust cash position supported by a $1.775 million R&D tax refund for the quarter ended 31 March 2025.

Optiscan Imaging Ltd reported a productive December quarter, marked by key product developments, strategic partnerships, and a stronger cash position, setting the stage for growth in medical and veterinary imaging markets.

Algorae Pharmaceuticals reports robust progress in its drug development pipeline, highlighted by promising preclinical results for cardiovascular and dementia candidates and significant AI platform enhancements.