Latest Regulatory Approval News

Saluda Medical has received CE certification for its EVA™ Sensing Technology, enabling commercialisation in Europe and recognition in Australia following prior FDA approval. This milestone sets the stage for a broader rollout of its personalised spinal cord stimulation therapy in early 2026.

Global Uranium and Enrichment Limited (GUE) has registered its scheme booklet with ASIC, detailing the proposed acquisition by Snow Lake Resources Ltd. The independent expert report supports the fairness and reasonableness of the deal, with GUE directors unanimously recommending shareholder approval.

Blue Star Helium has successfully started helium production at its Galactica project in Colorado, positioning itself as America’s newest helium producer with sales targeted for early 2026. The company’s strategic joint venture and low-cost operations underpin a promising growth trajectory amid rising helium and CO₂ demand.

Seven West Media shareholders have overwhelmingly approved the proposed acquisition by Southern Cross Media Group, clearing a major hurdle ahead of final court approval.

Seven West Media shareholders convened on 22 December 2025 to vote on a landmark acquisition by Southern Cross Media Group, potentially reshaping Australia's media landscape. The proposed scheme promises a combined media powerhouse spanning television, digital, audio, and publishing.

Midas Minerals has completed its acquisition of the Otavi Copper Project in Namibia, initiating multiple drilling programs across high-grade deposits and securing strong funding to drive exploration in 2026.

Cyclopharm Limited has secured regulatory approval for its Technegas lung imaging technology in Colombia, marking its presence in 67 countries worldwide. This milestone aligns strategically with the upcoming global nuclear medicine congress in Cartagena.

Clarity Pharmaceuticals has secured positive FDA guidance to initiate a pivotal Phase III trial of its Cu-64 SARTATE diagnostic agent for neuroendocrine tumours, aiming to improve detection and patient outcomes.

BioMarin Pharmaceutical’s acquisition of Amicus Therapeutics for US$4.8 billion includes Dimerix’s US licensing agreement, promising significant milestone payments and royalties. This deal strengthens Dimerix’s position as it advances its Phase 3 kidney disease therapy.

Aurizon has lodged a proposed ten-year Network Access Undertaking with the Queensland Competition Authority, aiming to secure long-term certainty and enhanced operational incentives for the Central Queensland Coal Network.

Memphasys has inked a five-year supply agreement with Italy’s Centro Fertilita Assistita, marking its first major European contract and setting the stage for broader adoption of its Felix™ sperm isolation system.

Champion Iron Limited has announced a conditional cash tender offer to acquire Norwegian iron ore producer Rana Gruber for approximately US$289 million, backed by key financial partners La Caisse and Scotiabank. The deal aims to expand Champion’s high-grade iron ore portfolio and strengthen its position in the green steel supply chain.