Latest Regulatory Milestones News

MRG Metals’ joint venture partner Sinowin Lithium has delivered a comprehensive Environmental and Social Impact Assessment for the Corridor Central Titanium Dioxide project in Mozambique, marking a key regulatory milestone towards production in 2027.

CLINUVEL Pharmaceuticals has received final scientific advice from the European Medicines Agency on the design of its pivotal Phase III trial for SCENESSE in vitiligo, endorsing a comprehensive evidence approach and prioritising patients with darker skin tones.

EBR Systems secures Priority Review from Australia's TGA for its wireless cardiac pacing system, fast-tracking regulatory approval and expanding access for heart failure patients. This follows strong US commercial momentum after FDA approval.

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.

BCAL Diagnostics has expanded its Avantect cancer blood tests nationally through major pathology networks, generating $88,000 in Q3 revenue from 91 tests. The company also submitted an initial Medicare reimbursement application for pancreatic cancer detection and is preparing to launch an enhanced BREASTESTplus 2.0 test in early 2027.

Paladin Energy has increased its FY2026 uranium production guidance at the Langer Heinrich Mine to 4.5-4.8 million pounds, driven by strong operational performance. Concurrently, the company secured environmental approval for its Patterson Lake South project in Canada, although a legal challenge looms.

South32's March quarter saw a tragic fatality at Worsley Alumina and weather disruptions, yet the miner delivered solid operational results and progressed its Hermosa zinc-lead-silver project. Production guidance was mostly maintained, with a notable revision lower for Australia Manganese due to water management issues.

Recce Pharmaceuticals has cleared a critical regulatory hurdle in Indonesia with a successful inspection of its Phase 3 clinical trial site for diabetic foot infections, paving the way for potential approval in 2026 amid a large and growing market.

Starpharma has secured FDA alignment on the clinical development plan for its DEP® HER2 radiotherapy candidate, paving the way for a first-in-human phase 1 study in advanced HER2-positive cancers scheduled for H2 2026.

Boab Metals has secured a six-year diesel supply deal with Cambridge Gulf subsidiary CGL Fuel, ensuring fuel reliability for Sorby Hills as it advances toward production in late 2027.

VHM Limited has ditched its Shenghe Resources offtake agreement to broaden market options and approved a direct jump to full-scale 5Mtpa development at its Goschen Rare Earths and Mineral Sands Project. Key regulatory approvals and a major drilling campaign underpin progress towards a mid-2026 Final Investment Decision and production slated for late 2027.

4DMedical lands a contract with pharma giant GSK, gains UKCA certification for its CT:VQ™ lung imaging technology, and joins the S&P/ASX 200, marking a significant step in its global expansion.