Latest Us Regulatory News

Emyria has unveiled the Empax Global Partnership Program, a high-margin clinical delivery platform targeting international drug sponsors amid growing demand for psychedelic-assisted mental health treatments.

Orthocell’s Q1 FY26 revenue hits $3.2 million, buoyed by growing US sales of its Remplir nerve repair device and a robust $48 million cash position supporting global expansion.

Patrys has initiated manufacturing and regulatory steps for RLS-2201, its injectable Quetiapine formulation targeting delirium, aiming for Phase 0 trials in the second half of 2026.

LTR Pharma has finalised recruitment for its Phase II clinical trial of SPONTAN, a rapid-acting intranasal spray for erectile dysfunction, with initial results expected in the second quarter of 2026.

Island Pharmaceuticals reports a 213.8% increase in half-year loss to $4.81 million, driven by strategic acquisition and clinical development investments. The company advances its antiviral portfolio with Galidesivir and ISLA-101, supported by strong US regulatory engagement and a $9 million capital raise.

Viking Mines has completed due diligence on its Nevada tungsten portfolio, confirming high-grade mineralisation and fast-tracking acquisition and exploration to meet urgent US supply needs.

CSL Limited reported a 7% decline in underlying NPATA to US$1.9 billion for the half-year, weighed down by restructuring costs and impairments, yet maintains full-year guidance and expands its share buy-back program.

Nova Minerals plans to redomicile to the United States following the loss of its foreign private issuer status, while acquiring full ownership of its Estelle Gold and Critical Minerals Project and appointing a US-based CFO.

Imricor Medical Systems has secured Virginia Commonwealth University Health as the third US site for its VISABL-AFL clinical trial, advancing its FDA approval pathway for MRI-guided cardiac ablation technology.

Energy Transition Minerals (ETM) has appointed Ballard Partners as strategic advisors in the US, reinforcing its plan to list on the Nasdaq Stock Exchange and deepen its engagement with American stakeholders.

4DMedical has gained Canadian regulatory approval for its innovative CT – VQ™ ventilation-perfusion imaging technology, enabling immediate commercial rollout through Philips and expanding its North American footprint.

The Australian Treasurer has approved Hanwha Corporation’s increase of its direct equity stake in Austal Limited from 9.9% to 19.9%, setting the stage for potential strategic partnerships as Austal rides a wave of record revenues and defence contracts.