Latest Us Regulatory News

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.

PainChek Ltd has secured FDA De Novo clearance for its Adult App, marking a pivotal entry into the US long-term care market and setting the stage for global expansion including its Infant App.

Prescient Therapeutics has achieved a key regulatory milestone with the European Medicines Agency granting Orphan Drug Designation for its PTX-100 therapy targeting Cutaneous T-cell Lymphomas, enhancing its commercial and clinical prospects in Europe.

Mandrake Resources has signed a term sheet with DISA Technologies to explore recovering uranium and critical minerals from abandoned mine waste in Utah, leveraging a unique US regulatory license and strong government backing.