Latest Regulatory Milestones News

Manuka Resources’ Taranaki VTM Project has cleared a key regulatory hurdle, moving forward in New Zealand’s Fast-track Approvals Process with promising economic and environmental prospects.

Mesoblast has been granted a seven-year orphan-drug exclusivity by the FDA for its cell therapy Ryoncil, reinforcing its market position in treating steroid-refractory acute graft versus host disease in children.

Anson Resources has gained regulatory approval to re-enter a historic well at its Green River Lithium Project, aiming to deepen the reservoir and advance its lithium resource definition. This move sets the stage for a critical feasibility study that could underpin future lithium production.

Paradigm Biopharmaceuticals has secured centralised US ethics approval for its pivotal Phase 3 trial of injectable pentosan polysulfate sodium (iPPS) targeting moderate to severe knee osteoarthritis, setting the stage for patient enrolment in Q3 2025.

Estrella Resources has upgraded four reconnaissance permits to exploration licenses in Timor-Leste, significantly enlarging its landholding and enabling advanced exploration activities targeting manganese and limestone deposits.

Carbine Resources has been granted a long-term mining lease for its Muchea Silica Sand Project, marking a significant step forward while awaiting further regulatory approvals.

EBR Systems has won FDA approval for its pioneering leadless WiSE CRT System, setting the stage for a phased US commercial rollout. The company also secured key Medicare reimbursement pathways and expanded manufacturing capacity, though financial sustainability remains a concern.

Anteris Technologies Global Corp. reported a $21.9 million net loss for Q1 2025, driven by increased R&D spending as it scales manufacturing and prepares pivotal trials for its DurAVR Transcatheter Heart Valve. The company’s recent $80 million IPO proceeds are being deployed to support these efforts and repay debt.

Marvel Gold Limited has made significant progress in acquiring the Hanang Gold Project in Tanzania, submitting all regulatory documents and anticipating approvals soon. The company also prepares for its Annual General Meeting where shareholders will vote on a $2.5 million capital raising placement.

PolyNovo has secured Therapeutic Goods Administration clearance for thicker versions of its NovoSorb MTX product, broadening treatment options for complex wounds in Australia.

Black Rock Mining's subsidiary Faru Graphite Corporation has inked pivotal agreements with TANESCO to build a $40 million power line, connecting the Mahenge Graphite Project to Tanzania’s hydro-powered grid. This milestone enhances the project’s green credentials and de-risks its path to production.

Emperor Energy's Environmental Plan for the Judith-2 Well has passed NOPSEMA's completeness check and is now open for public comment, marking a key regulatory milestone on the path to drilling in mid-2026.