Latest Us Regulatory News

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.

Brookside Energy reported a 50% increase in Proved Developed Producing reserves and steady production in Q1 2025, while progressing preparations for a US listing on the NYSE.

LTR Pharma reports strong Q1 2025 progress with FDA pre-IND meeting success, scientific acclaim for SPONTAN’s rapid absorption, and strategic launch of ROXUS to fast-track US market entry.

Australian Oil Company Limited (AOK) reports significant progress in its California pipeline acquisition and appoints Chris Hodge as Non-Executive Chairman, signaling a strategic push into US gas exploration.