Latest Regulatory Approvals News

Artrya Limited has submitted a pivotal FDA 510(k) application for its AI-powered Salix® Coronary Plaque module, aiming for clearance in Q3 2025 and a lucrative US commercial launch.

Santos Limited has received a compelling non-binding proposal from the XRG Consortium to acquire the company at a significant premium, prompting the board to engage in due diligence and negotiations. This move could reshape the Australian energy landscape if finalized.

EVE Health Group’s subsidiary Nextract has inked a pivotal two-year agreement with TeleDocs Clinic, enabling nationwide online prescribing of its upcoming erectile dysfunction and dysmenorrhea products ahead of regulatory approval.

EMVision Medical Devices has secured a $5 million non-dilutive government grant to accelerate global commercialisation of its innovative First Responder portable brain scanner, aimed at revolutionising pre-hospital stroke and brain injury care.

Talga Group’s Nunasvaara South graphite mine zoning plan process shifts to regional government after local deadline missed, advancing a key step in Sweden’s battery materials push.

Bubs Australia has submitted critical clinical trial data to the US FDA, marking a pivotal step toward permanent approval for its infant formulas in the US market.

Lunnon Metals has completed a detailed Scoping Study for its Lady Herial gold deposit, confirming a short-life, high-grade open pit opportunity with strong financial prospects. The study, based largely on Measured and Indicated Resources, sets the stage for commercial negotiations with Gold Fields and potential near-term production.

Tourism Holdings Limited has received a conditional, non-binding takeover proposal from a consortium led by BGH Capital and the Trouchet family, signaling a possible shift in ownership for the global RV rental giant.

VBX Limited is set to raise $10 million through an initial public offering to fund the development of its Wuudagu Bauxite Project in Western Australia, supported by a positive pre-feasibility study and strong market fundamentals driven by China’s growing aluminium demand.

Yowie Group Ltd has initiated an off-market takeover bid to acquire Keybridge Capital Limited, offering one Yowie share for each Keybridge share amid Keybridge's financial distress and administration history.

Silk Logistics has announced a postponement of its shareholder Scheme Meeting due to an extended review by the Australian Competition and Consumer Commission (ACCC) of DP World Australia’s proposed acquisition.

Renascor Resources has received provisional development authorisation from South Australia’s Minister for Planning to build a commercial-scale battery anode material plant, marking a pivotal step in its vertically integrated graphite project.