Latest Us Regulatory News

Global Uranium and Enrichment Limited has completed a transformative acquisition of the Pine Ridge Uranium Project in Wyoming, initiating a large-scale drilling program that positions the company as a key domestic uranium developer in the US.

Neurotech International reports encouraging Phase I human pharmacokinetic results for its pediatric cannabinoid drug NTI164, alongside published clinical trial data in Rett Syndrome and key regulatory progress in the US and Australia.

ReNerve Limited reported a robust 53% increase in annual revenue, driven by strategic partnerships and new regulatory approvals that broaden its global footprint in nerve repair.

Imricor Medical Systems has secured key European regulatory approvals for its second-generation NorthStar system and initiated its commercial launch, while US FDA submissions progress amid some delays.

Bubs Australia has submitted critical clinical trial data to the US FDA, marking a pivotal step toward permanent approval for its infant formulas in the US market.

Hanwha Group claims US approval to fully own Austal, but independent checks suggest a narrower green light. Australian regulators still hold the final say on foreign ownership.

PainChek has advanced its US regulatory approval process with a positive FDA meeting, setting the stage for a potential market debut of its pain assessment app in late 2025.

Terra Uranium has completed key airborne geophysics surveys and is gearing up for a coordinated 2025 drilling campaign on its Athabasca Basin projects, positioning itself to benefit from a strengthening uranium market.

Anson Resources has gained approval from the US Bureau of Land Management to re-enter a historic well at its Green River Lithium Project, advancing its efforts to define a JORC Mineral Resource. This milestone underscores the project's potential and positions Anson closer to securing critical financing.

Dimerix has inked an exclusive US licensing agreement with Amicus Therapeutics for DMX-200, a promising Phase 3 treatment for FSGS, unlocking $30 million upfront and up to $560 million in milestones.

Cardiex reports strong early sales momentum for its CONNEQT Pulse device with approximately 3,000 units sold or contracted since its mid-January launch, supported by innovative app features and operational efficiencies. Despite regulatory delays in the US pharma sector and tariff challenges, the company is positioned for scalable growth and category leadership in preventative cardiovascular care.

Tissue Repair Limited reports progress in its Phase 3 clinical trials for TR987® despite enrollment delays caused by US regulatory disruptions, while TR Pro+® sales hit record highs and manufacturing scale-up advances.