Latest Regulatory Milestones News

OncoSil Medical has won FDA Humanitarian Device Exemption approval for its OncoSil™ device to treat distal cholangiocarcinoma, opening a US market estimated at A$80 million annually.

Archer Materials has pinpointed a capillary blood collection method that matches venous samples in haemolysis levels, advancing its potassium Biosensor development towards integrated clinical testing.

NeuroScientific Biopharmaceuticals (ASX:NSB) has locked in a key FDA Pre-IND meeting for late August, advancing its Phase 2 trial plans for StemSmart™ targeting refractory Crohn’s disease in the US and Australia.

Anteris Technologies posted a $51.7 million loss in H1 2026 amid ramped-up R&D and clinical trial activity, supported by a $320 million capital raise and Medicare reimbursement for its DurAVR heart valve trial.

EBR Systems marked a commercial milestone with over 100 WiSE CRT implants and secured purchasing agreements with three major US healthcare networks. The company is progressing toward Medicare coverage and scaling manufacturing, supported by a near-complete A$150 million capital raise.

Lake Resources has completed a A$1.1 million at-the-market equity raise at a 7.6% discount, directing funds towards advancing environmental and power optimisation efforts at its Kachi lithium project.

Maritana Minerals has secured key regulatory approvals and is progressing critical non-process infrastructure at its Black Swan Processing Hub, keeping the project on track for first gold production in the second half of 2027.

Acrow Limited has secured Phase 1 clearance from the ACCC for its AusGroup Industrial Services acquisition, removing a key regulatory hurdle and setting the stage for completion by the end of August.

Starpharma has successfully completed a $32 million entitlement offer, nearly fully subscribed, to fund its DEP® HER2-Lutetium Phase 1 trial and further develop its oncology pipeline.

ReNerve Limited has gained marketing approval for its flagship NervAlign Nerve Cuff in India, marking a critical milestone in its global expansion and enabling commercial rollout in one of the world's largest nerve repair markets.

Sky Metals releases a Pre-Feasibility Study confirming Tallebung's robust economics with a 7.3-year mine life, strong cashflows, and rapid capital payback, targeting mid-2028 production.

Flynn Gold is kicking off a 2,500m drilling campaign at its Brilliant Prospect in northeast Tasmania, aiming to convert promising trench assay results into a formal Mineral Resource and fast-track project development.