Latest Regulatory Milestones News

Cleo Diagnostics has received encouraging feedback from the U.S. FDA on its ovarian cancer pre-surgical triage test, reinforcing its clinical trial design and regulatory strategy ahead of a critical 510(k) submission.

Bioxyne Limited has secured import permits and purchase orders worth A$5.1 million for medical cannabis in Germany, signaling strong early traction in a key European market.

Actinogen Medical has reached a pivotal agreement with the US FDA outlining the regulatory and clinical trial requirements for Xanamem’s approval in Alzheimer’s disease, setting a clear path toward a US marketing application.

AVITA Medical has secured the CE Mark for its innovative RECELL GO device, paving the way for commercialization across key European markets including Germany, Italy, and the UK. This regulatory milestone expands the company’s footprint in acute wound care.

Vulcan Energy has gained City of Landau Council approval to acquire land for its pioneering geothermal and lithium extraction plant, marking a crucial step toward sustainable energy and lithium supply in Europe.

Beacon Minerals has secured critical regulatory approvals for the Iguana Deposit, setting the stage for mining operations and a comprehensive five-year resource development strategy.

Artrya Limited has raised A$75 million through a two-tranche placement and launched a A$5 million share purchase plan to fast-track the U.S. commercialisation of its AI-powered Salix platform following FDA clearance.

Telix Pharmaceuticals has secured FDA agreement on a resubmission plan for its glioma imaging agent TLX101-CDx, aiming for a Q4 2025 filing that includes additional efficacy data. The FDA signals likely expedited review, underscoring the unmet medical need.

Genesis Minerals has secured regulatory approval for Stage One mining at Tower Hill, aligning the project with its mill expansion plans and setting the stage for production in FY28.

Alterity Therapeutics has raised A$20 million through a strategic placement to advance its promising ATH434 treatment for Multiple System Atrophy, backed by encouraging Phase 2 trial results. The capital injection strengthens the company’s balance sheet as it prepares for regulatory discussions with the FDA.

Imagion Biosystems has reached key milestones in its MagSense® HER2 breast cancer imaging program, including starting manufacturing for its Phase 2 trial and launching an AI imaging protocol collaboration with Wayne State University.

Boab Metals has extended its option to acquire full ownership of the Sorby Hills Project to the end of 2025, while locking in critical commercial agreements and environmental approvals that pave the way for a final investment decision.