Latest Regulatory Reviews News

CurveBeam AI reported stable device orders but faces regulatory delays for FDA and China clearances, while securing a A$4 million investment from WEGO Orthopaedics and advancing clinical collaborations with robotic surgery systems.

Rakon Limited has swung back to profit in FY26, reporting a 24% revenue lift and doubling EBITDA, while Bourns' takeover offer edges closer to completion with 85% shareholder acceptance and pending French regulatory approval.

Equatorial Resources has completed its final arbitration submissions against the Republic of Congo with a final ICSID award expected in the first half of 2027. Meanwhile, the company continues to seek clarity on the status of its iron ore exploration permits in Guinea amid ongoing regulatory uncertainty.

Siren Gold continues its push to upgrade the Sams Creek gold resource with ongoing drilling and a mining permit application nearing decision. Meanwhile, exploration at Queen Charlotte reveals extensive high-grade gold and antimony mineralisation, underpinning the company’s strategic growth in New Zealand’s critical minerals sector.

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.

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.

Rua Gold has lodged a Fast-Track Referral application for its Auld Creek gold and antimony project in New Zealand's Reefton Goldfield, aiming to speed up permitting and development under new government legislation.

Telix Pharmaceuticals has announced FDA acceptance of its resubmitted NDA for TLX101-Px (Pixclara®), a PET imaging agent for glioma, setting a PDUFA goal date of September 11, 2026. The agent addresses a significant unmet need in distinguishing recurrent glioma from treatment effects.

Algorae Pharmaceuticals has reached a key regulatory milestone as the TGA accepts its initial registration dossier, paving the way for potential commercialisation of its generic medicines in Australia and New Zealand.

PMET Resources has submitted the Environmental and Social Impact Assessment for its Shaakichiuwaanaan CV5 Lithium Project, marking a pivotal step in securing regulatory approvals. This follows a positive feasibility study and extensive Indigenous engagement.

Optiscan Imaging Ltd has taken a significant step towards commercialising its InSpecta® veterinary imaging device in the US by submitting a regulatory dossier to the FDA. This milestone not only initiates formal review but also sets the stage for broader clinical adoption and future device approvals.

Echo IQ has strengthened its partnership with Mayo Clinic to distribute its AI-driven heart failure diagnostic tool, EchoSolv HF, pending FDA clearance. The expanded agreement offers a scalable commercial pathway across a vast US hospital network.