Latest Regulatory News

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.

Washington H. Soul Pattinson and Brickworks have secured Supreme Court approval for their share schemes, paving the way for the launch of Topco shares on the ASX. Shareholders will transition to Topco shares starting next week, marking a significant step in the companies’ strategic consolidation.

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.

WhiteHawk Limited and DoxAI have forged a three-year strategic partnership to integrate AI-driven automation with advanced cyber risk and compliance solutions, aiming to accelerate digital transformation across key sectors in North America and Australia.

Codeifai Limited has integrated GS1 Digital Link functionality into its ConnectQR platform, positioning itself at the forefront of the global transition from traditional barcodes to smart 2D codes.

EVE Health Group has appointed Dr Fiona Cousins as the inaugural member of its Scientific Advisory Board, reinforcing its commitment to advancing treatments for dysmenorrhoea and endometriosis ahead of the commercial launch of Dyspro™.

Invictus Energy has extended its Exclusive Prospecting Orders in Zimbabwe’s Cabora Bassa Basin for another three years, setting the stage for a high-impact exploration campaign including the Musuma-1 well targeting substantial gas and condensate resources.

Infini Resources Limited has launched a A$3 million flow-through share offer targeting its Canadian uranium projects, aiming to advance exploration amid regulatory and financing challenges.

St Barbara Limited has withdrawn its Supreme Court appeal over reclamation conditions at the Touquoy Mine, citing improved regulatory cooperation in Nova Scotia, and is now investigating reopening the mine to process 3.1 million tonnes of low and medium grade gold stockpiles.

An independent study confirms Condor Energy’s Piedra Redonda gas field offshore Peru offers multiple viable pathways to early monetisation and long-term growth, positioning it as a strategic regional energy asset.

St Barbara Limited reveals strategic progress on its Simberi Sulphide Expansion and Atlantic Projects, underpinning a robust production outlook and advancing key regulatory approvals.

Vault Minerals reports a 31% increase in gold Ore Reserves to 4 million ounces and a 3% rise in Mineral Resources to 12.2 million ounces as of June 2025, driven by strong growth at Leonora, Sugar Zone, and Mount Monger.