Latest Us Regulatory News

Elixinol Wellness has finalized the divestment of its US operations to Ananda Health, securing upfront and deferred payments totaling approximately A$465,000. This move refocuses the company on its Australian health and wellness portfolio while reducing exposure to US regulatory risks.

Optiscan Imaging has launched a 35-patient clinical trial in the US to test its InVue™ and InForm™ platforms in head and neck cancer surgery, aiming to bolster its FDA submissions later this year.

Orthocell posts record FY26 revenue growth driven by expanding US and international sales of its collagen medical devices, while investing ahead in manufacturing capacity and product pipeline.

AdAlta Limited (ASX:1AD) has progressed its ‘East to West’ cellular immunotherapy strategy by securing its first CAR-T asset, advancing Australian manufacturing and US FDA regulatory engagement, while raising A$5.3 million in FY2026 and reporting a net loss of $4.68 million.

SQX Resources launches a fully underwritten $2.47 million rights issue at a 31% discount to fund accelerated exploration across key US and Australian projects.

Mesoblast has treated 350 patients in its pivotal Phase 3 trial for rexlemestrocel-L, targeting chronic low back pain linked to degenerative disc disease, setting the stage for top-line results in mid-2027.

Dateline Resources faces a US court injunction halting operations at its Colosseum Project, while ASX suspends and then reinstates trading over disclosure timing concerns.

AdAlta’s lead CAR-T therapy EW-001 continues to demonstrate encouraging survival and response rates in its mesothelioma study, with all patients alive at the latest follow-up and stronger outcomes at higher doses supporting plans for an Australian Phase 1 trial.

OD6 Metals has completed its acquisition of the Quinn Fluorspar Project, consolidating 100% ownership of 226 mining claims in Nevada and positioning itself as a potential key domestic fluorspar supplier for the US.

Control Bionics has achieved FDA registration for its NeuroStrip surface EMG platform, cementing its medical device status in the US and bolstering its appeal in clinical and research markets.

OncoSil Medical reported a 53% increase in unit sales and advanced key regulatory approvals, including FDA final review and TGA listing, positioning it for growth in pancreatic cancer treatment.

Aurora Energy Metals progresses the Aurora Uranium Project with a major drill program imminent under Eagle Nuclear Energy, while broadening its Western Australian footprint with new exploration licences at Mukinbudin.