Latest Regulatory Approval News

ReNerve Limited has secured broader regulatory approval in Hong Kong for its NervAlign® Nerve Cuff, enabling access to both public and private hospitals and validating the device’s clinical benefits through independent review.

Clinuvel Pharmaceuticals has initiated dosing in a preclinical study of its novel controlled-release injectable peptide platform, VLRX-L, aiming to enhance drug delivery for melanocortin-based therapies. Preliminary results are expected in the second half of 2026.

Imricor Medical Systems has achieved a major milestone with FDA clearance for its Vision-MR Diagnostic Catheter, paving the way for commercial sales in the US electrophysiology market.

Haranga Resources has confirmed a significant continuous gold mineralised trend exceeding 800 metres at its Ibel South Gold Project in Senegal, with plans for deeper drilling in early 2026 to explore high-grade zones and untested anomalies.

Lunnon Metals has reported significant gold intercepts at its Paringa West prospect, confirming a promising new geological structure within the prolific St Ives gold camp. The results bolster the company’s exploration ambitions in Western Australia’s renowned Foster-Baker Project.

Fatfish Group Limited has refinanced its $5.67 million debt with Arena Investors LP and secured an additional $0.15 million through new convertible notes, including a board nomination right for Arena.

BPH Global has refined its Project 6-7 R&D program to concentrate on recovering gold and silver from seaweed, aiming to fast-track commercialisation of this innovative bio-mining approach.

Canyon Resources advances its Minim Martap Bauxite Project with mining set to start in February 2026 and first shipments targeted for late June, underpinned by key operational milestones and strategic partnerships.

Estrella Resources has gained regulatory approval to extract a 30,000-tonne bulk sample of high-grade manganese from its Ira Miri project, marking a pioneering step for Timor-Leste’s mining sector under its modern Mining Code.

Lindian Resources reports strong construction progress at its Kangankunde Rare Earths Project in Malawi, highlighted by the arrival of its Komatsu owner-operator mining fleet and advancing infrastructure works.

Lunnon Metals has secured the last regulatory approval needed to advance its Lady Herial gold project, bringing it closer to production under a key agreement with St Ives Gold Mining.

Hydrix Limited’s subsidiary has landed a significant A$2.5 million contract to develop SynCardia’s next-generation fully implantable Total Artificial Heart, marking a major step in advanced cardiovascular technology.