Latest Us Regulatory Approvals News

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.

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.

Island Pharmaceuticals has submitted a detailed briefing to the FDA aiming to accelerate approval of its antiviral Galidesivir for Marburg virus under the Animal Rule, with feedback expected by November.

ReNerve Limited reported a robust 53% increase in annual revenue, driven by strategic partnerships and new regulatory approvals that broaden its global footprint in nerve repair.

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.