Latest Regulatory Approvals News

BlinkLab has expanded its pivotal FDA 510(k) autism diagnostic trial to nine top U.S. sites, adding Drexel University ahead of the Q1 2026 study start. This move follows a successful pilot study that exceeded FDA benchmarks, positioning BlinkLab Dx 1 for regulatory clearance.

Axel REE is fast-tracking field recovery trials at its Caladão Project, leveraging proven in situ recovery methods and a rare gallium resource to position itself uniquely in the critical minerals space.

Matsa Resources launches a major drilling campaign at Fortitude North targeting up to 1.85 million ounces of gold, supported by a $17.5 million loan facility from major shareholder Deutsche Balaton.

Titanium Sands Limited has responded to ASX inquiries following a sharp share price drop and increased trading volume, confirming no undisclosed price-sensitive information. The company highlighted an unrelated Sri Lankan Supreme Court petition on illegal mining near its pending Mannar Island project.

Novo Resources has significantly increased the Exploration Target at its Belltopper Gold Project in Victoria, with multiple high-grade prospects across its Australian portfolio and drilling programs planned throughout 2026.

Tamboran Resources has appointed Todd Abbott as CEO and made significant progress in drilling and infrastructure development in the Beetaloo Basin, aiming for first gas sales in the third quarter of 2026.

Vita Resources NL has secured regulatory approval to launch its first-ever exploration drilling campaign at the promising Ninnis Gold Project in Western Australia’s Northern Goldfields.

Meteoric Resources has successfully commissioned its Mixed Rare Earth Carbonate pilot plant in Brazil, achieving strong recovery rates and production outputs that validate its processing approach and de-risk the Caldeira project.

Racura Oncology has developed a pioneering blood test that promises to fast-track key data on its cardioprotective drug RC220, potentially shaving two years off the clinical trial timeline. This innovation also enhances patient safety and recruitment prospects in the ongoing RAC-010 CPACS trial.

Tivan Limited’s maiden drilling at the Sandover Fluorite Project has delivered ultra high-grade fluorite assays, confirming a robust mineralised system with promising metallurgical qualities. The company is gearing up for a significant follow-up drilling campaign to expand resource definition.

Grand Gulf Energy’s initial fieldwork at its Dry Wash Antimony Project in Utah reveals visible stibnite mineralisation, hinting at promising shallow deposits linked to nearby known mineral systems.

Argenica Therapeutics has reported a significant increase in its half-year loss to $3.82 million, driven by reduced revenue and higher research and development expenses. The company continues to invest heavily in its neuroprotective drug candidate ARG-007 amid ongoing clinical trials.