Latest Regulatory Approval News

AFT Pharmaceuticals has received tentative US FDA approval for its Scomara cream to treat Facial Angiofibromas in Tuberous Sclerosis, but US commercialisation is postponed until 2029 due to orphan drug exclusivity. The approval bolsters regulatory prospects in other key markets where AFT anticipates competitive advantages.

Havilah Resources has kicked off reverse circulation drilling at its Brooks Dam prospect near Kalkaroo, aiming to penetrate a stubborn gossan-chert horizon and better define underlying copper-gold mineralisation. The drilling is part of a strategic alliance with Sandfire Resources, which is also advancing its own large-scale drilling and prefeasibility work at Kalkaroo.

Energy Transition Minerals (ASX:ETM) has completed its purchase of the Penouta Tin-Tantalum-Niobium mine in Spain, advancing its ambition to become a key European critical minerals producer with plans to restart operations.

Aeris Resources has reported a substantial 70% jump in Mineral Resources and a fourfold increase in Ore Reserves at its Tritton Operations, driven by the Peel Mining acquisition and successful exploration at key deposits.

Condor Energy has completed its Technical Evaluation Agreement work early, consolidated full ownership of TEA 86 offshore Peru, and submitted for licence conversion, positioning itself for exploration and gas commercialisation.

Klevo Rewards has completed the acquisition of Just Ask Solar, gaining an Australian Credit Licence to support its digital financial services platform and explore credit products, including crypto-linked offerings.

AIC Mines projects copper production growth to 18,500 tonnes in FY27, driven by Jericho mine's commercial start and accelerated Eloise plant expansion.

OncoSil Medical has gained Saudi FDA approval for its OncoSil™ device, enabling full reimbursement and commercial access in Saudi Arabia, the Middle East's largest healthcare market.

Fenix Resources has secured crucial regulatory and environmental approvals for its Beebyn-W10 iron ore mine, adjacent to Beebyn-W11, forming the Beebyn Hub. This milestone underpins the company’s 3-Year Production Plan aiming for up to 6 million tonnes per annum by FY28.

True North Copper (ASX:TNC) has agreed to sell its Bundarra Copper Project to Tec Minerals, securing A$500,000 cash, A$1 million equity in Tec Minerals, and a 1% Net Smelter Royalty, as it sharpens focus on its Mt Oxide and Cloncurry copper developments.

ECS Botanics delivered a fourth consecutive quarter of positive operating cash flow in Q4 FY26, with a full-year turnaround of $5.9 million. The company’s branded B2C revenue surged 31% year-on-year, supported by product launches and European market expansion.

NH3 Clean Energy (ASX:NH3) has updated investors on its WAH2 Project, aiming for commercial operations by 2030 to produce low-emissions ammonia for Asia-Pacific markets. The presentation highlights strategic advantages, partnerships, and a phased development plan amid ongoing contract and financing negotiations.