Latest Regulatory Approvals News

Cambium Bio has secured FDA confirmation that a single pivotal Phase 3 trial plus confirmatory evidence will suffice for Biologics License Application submission for Elate Ocular, significantly reducing development expenses and accelerating the pathway to market.

Wide Open Agriculture appoints Craig Swan as CEO and pivots to a contract manufacturing model to improve economics and scale lupin protein production, while receiving a A$1.69 million R&D tax rebate.

Dreadnought Resources has obtained regulatory approval for open pit mining at its Star of Mangaroon gold project in Western Australia, advancing its strategy to become a self-funded explorer by outsourcing development and processing.

Little Green Pharma has pushed back the Federal Court hearing for its Cannatrek acquisition to late May, setting a new timetable that includes a shareholder vote on May 22 and implementation targeted for June 1.

Radiopharm Theranostics (ASX: RAD) has completed enrolment in its Phase 2b RAD 101 brain metastases imaging trial with interim data showing 90% concordance with MRI, while progressing early-stage trials of therapeutic candidates RAD 202, RV-01, and RAD 402. The company reported a $19.2 million cash balance at quarter end, down from $34.5 million, with a net operating cash outflow of $14.9 million driven by milestone-related R&D and staff costs.

Barton Gold has launched a ~3,000m diamond drilling campaign at its Tunkillia project, aiming to upgrade resources and support a Mining Lease application by the end of 2026. The project builds on a strong May 2025 study projecting robust returns amid rising gold and silver prices.

Macro Mining Services has partnered with Austral Pacific to tap into gold tailings and stockpiles at the Paris Gold Mine, aiming to turn historical waste into revenue through a 50:50 profit share after expense recovery.

Prospect Resources has significantly boosted its Mumbezhi Copper Project resource base by 63%, lifted contained copper by 50%, and secured A$45 million in fresh capital to fund an aggressive drilling campaign starting May 2026.

Star Minerals has secured final approvals and commenced site mobilisation at its Tumblegum South Gold Project, bolstered by strong drilling results and a $2.75 million sale of non-core assets to Catalyst Metals.

Emerald Resources NL posted a record March quarter pre-tax operating cash flow of A$143 million from its Okvau Gold Mine, maintaining full-year gold production guidance while progressing development and exploration at its Dingo Range and Memot projects.

Ampol has increased its divestment offer to the ACCC by four additional sites, raising the total to 41 as it pushes to satisfy competition concerns in its EG Australia acquisition. The move aims to secure regulatory clearance ahead of a mid-2026 transaction close.

Hastings Technology Metals is on track to commission its Kabin Buri Hydromet Plant in Thailand by June 2026, aiming for first production of premium Mixed Rare Earth Chloride flakes by Q4. The plant promises near-term revenue streams and leverages lower operating costs in Thailand's Eastern Economic Corridor.