Latest Regulatory Approval News

Imricor Medical Systems has taken a significant step toward U.S. market entry by submitting its Vision-MR Diagnostic Catheter for FDA 510(k) approval, complementing its recent NorthStar system filing. These moves aim to establish a fully integrated MRI-guided cardiac ablation platform.

Dundee Precious Metals has received court sanction for its recommended acquisition of Adriatic Metals, paving the way for a scheme of arrangement expected to take effect on 3 September 2025. The transaction will result in Adriatic shares being cancelled and DPM’s listing on the ASX as a foreign exempt entity.

Hartshead Resources has struck a pivotal Well Carry Agreement with RockRose Energy, securing full funding for its Phase C drilling costs while trimming its joint venture stake. The move also triggers a licence extension application amid UK regulatory delays.

SSH Mining Australia has entered a profit share mining agreement with High-Tech Metals to advance the Wagtail Gold Deposit, marking a pivotal step in the Mt Fisher Gold Project's development.

InFocus Group Holdings launches a new division focused on digital assets, AI, and big data, supported by a conditional $10 million financing from Mythos Group. The move aims to accelerate innovation in gamification and blockchain ventures.

Finder Energy is fast-tracking development of the Kuda Tasi and Jahal oil fields in Timor-Leste, targeting initial production rates of up to 40,000 barrels per day and 10 million barrels in the first 18 months. A strategic alliance with SLB is key to accelerating engineering and reducing project risks.

MAC Copper Limited shareholders have decisively approved the proposed acquisition by Harmony Gold, clearing a major hurdle for the transaction. The scheme now awaits final court sanction before becoming effective.

Recce Pharmaceuticals reported a 21% increase in net loss to $21.4 million for FY2025, driven by intensified R&D spending. The company secured key regulatory approvals for Phase 3 trials of its lead anti-infective gel and bolstered its financial position with significant capital raises and grants.

HALO Technologies reports a significantly improved half-year net loss and secures verbal FCA approval for its UK platform, while preparing to launch Managed Funds in Australia.

TerraCom Limited reported a statutory loss of A$33.7 million for FY2025 amid lower coal sales and prices, while progressing its Moorlands Thermal Coal Project in partnership with Wintime Energy Group.

Argent BioPharma reported a net loss of A$17.84 million for FY2025, reflecting a strategic pivot towards core drug development and clinical advancement. The company secured key EU approvals and raised significant capital to support its neuro-immune modulatory pipeline.

Osteopore Limited reported a 6% increase in revenue to $1.56 million for the half-year ended June 2025, alongside a slight rise in net loss driven by expanded product development and compliance costs. The company secured key regulatory approvals and broadened its distribution footprint in Asia and the US.