Latest Regulatory Clearance News

Anteris Technologies Global Corp. has raised A$38.5 million in a private placement to accelerate the global commercialization and pivotal clinical trial of its innovative DurAVR® transcatheter aortic valve replacement device.

Tetratherix reports encouraging safety and stability results from its Tutelix hydrogel spacer trial, initiates stage 2 recruitment, and secures a $3.3 million government grant to boost manufacturing capacity and R&D.

Cuscal Limited has secured a crucial regulatory win as the ACCC clears its full acquisition of Indue Limited, setting the stage for completion by year-end pending final approvals.

Lumos Diagnostics reported steady quarterly revenue with a 300% surge in product sales, driven by its flagship FebriDx® test. The company inked a landmark US$317 million exclusive U.S. distribution agreement and awaits FDA feedback on its CLIA waiver application.

Apiam Animal Health Limited has entered a binding agreement with Adamantem Capital Fund II for a $228.4 million acquisition via a scheme of arrangement, offering shareholders a significant premium and flexible cash or scrip consideration options.

BlinkLab Limited has completed its U.S. pilot study for the Dx 1 smartphone-based autism diagnostic device, demonstrating strong accuracy and securing FDA alignment for its pivotal trial. The results mark a significant step toward transforming early neurodevelopmental diagnostics.

Evergreen Lithium has secured key regulatory approvals to begin reverse circulation drilling at its Mt Monger Gold Project, targeting high-potential gold prospects Duchess of York and Kiaki Soaks. The campaign aims to unlock valuable insights and guide further exploration in 2026.

Mayne Pharma has announced the rescheduling of its Supreme Court hearing to November 3, 2025, to approve the acquisition scheme by Cosette Australia BidCo, pending Foreign Investment Review Board approval.

United States Antimony Corporation has proposed acquiring Larvotto Resources in a deal that could create one of the largest antimony producers outside China, offering Larvotto shareholders a significant premium.

Imricor Medical Systems has completed the world’s first Pulsed Field Ablation procedure under real-time MRI guidance, marking a breakthrough in cardiac ablation technology. This pre-clinical success validates their Vision-MR platform’s adaptability and sets the stage for safer, radiation-free heart treatments.

Tivan Limited has received regulatory clearance to begin drilling at its Sandover Fluorite Project, aiming to unlock high-grade fluorite deposits with assays reaching 94% CaF2. The staged drilling program marks a significant step toward defining a commercially viable resource.

PainChek Limited has appointed Sasha Grant as Head of Growth for its AI-powered Infant App, aiming to scale its presence in a $15 billion global market. Early Australian adoption shows promising conversion rates as the company prepares for international expansion.