Latest Us Regulatory News

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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.
Ada Torres
Ada Torres
10 July 2025
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.
Victor Sage
Victor Sage
16 June 2025
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.
Victor Sage
Victor Sage
10 June 2025
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.
Ada Torres
Ada Torres
5 June 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.
Maxwell Dee
Maxwell Dee
26 May 2025
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.
Maxwell Dee
Maxwell Dee
12 May 2025
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.
Ada Torres
Ada Torres
1 May 2025
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.
Ada Torres
Ada Torres
30 Apr 2025
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.
Ada Torres
Ada Torres
30 Apr 2025
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.
Maxwell Dee
Maxwell Dee
30 Apr 2025
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.
Ada Torres
Ada Torres
29 Apr 2025
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.
Maxwell Dee
Maxwell Dee
31 Jan 2025