Latest Regulatory Milestones 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.

Southern Cross Media Group has secured crucial ACMA approval for its proposed merger with Seven West Media, advancing a major consolidation in Australia’s media landscape. The deal now moves closer to final shareholder approval.

Seven West Media has secured crucial approval from the Australian Communications and Media Authority, advancing Southern Cross Media's acquisition plans. The upcoming scheme meeting in December will be pivotal for shareholders.

Audeara Limited has achieved a key regulatory milestone with NMPA certification in China, paving the way for commercial launch of its hearing personalisation technology through a leading e-commerce brand. This approval supports the company’s strategy to generate scalable licensing revenue in a rapidly growing market.

Right Resources has confirmed extensive high-grade gold mineralisation along a 1km strike at its Pilot Project in New South Wales, with maiden drilling now in progress to validate these promising findings.

Race Oncology has received ethics approval to launch its HARNESS-1 Phase 1a/b trial testing RC220 combined with osimertinib in EGFR-mutated non-small cell lung cancer patients, marking a key step toward addressing resistance to current therapies.

Cleo Diagnostics has secured a $1.7 million R&D tax refund, strengthening its cash reserves to $5.75 million as it advances toward a pivotal US clinical trial and FDA submission for its ovarian cancer test.

Genmin Limited has successfully completed the first tranche of its capital raising, issuing over 131 million shares to fund its flagship Baniaka iron ore project in Gabon, targeting production by late 2026.

Magnetite Mines has cleared a crucial regulatory hurdle as its Razorback Iron Ore Project’s Mining Lease Proposal passes the South Australian Government’s validity assessment, paving the way for detailed technical review and public consultation.

Redcastle Resources and BML Ventures have submitted a critical Mine Development and Closure Plan for their Queen Alexandra and Redcastle Reef deposits, setting the stage for gold production to commence in early 2026.

Santana Minerals has secured formal acceptance from New Zealand's Environmental Protection Authority for its Fast-track Approvals application, moving the Bendigo-Ophir Gold Project closer to construction.

Island Pharmaceuticals has secured membership in the Medical Countermeasures Coalition, positioning its antiviral Galidesivir for critical US government stockpiling and regulatory milestones.