Latest Regulatory Pathways News

Actinogen Medical has fast-tracked enrolment in its pivotal Alzheimer’s trial, secured a clear FDA regulatory path, and strengthened its financial position with funding extending its runway to mid-2026.

Island Pharmaceuticals secures FDA confirmation that regulatory feedback on Galidesivir’s approval pathway will arrive on schedule, underscoring the drug’s strategic importance amid US government disruptions.

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.

AdAlta Limited has raised up to A$1.1 million through a private placement, boosting its war chest to advance innovative cellular immunotherapy projects targeting solid cancers.

Algorae Pharmaceuticals has signed a binding term sheet with India’s Cadila Pharmaceuticals to introduce two generic medicines targeting cardiovascular and metabolic disorders in Australia and New Zealand.

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.

Ardea Resources has extended its Major Project Status for the Kalgoorlie Nickel Project, reinforcing its strategic role in Australia's critical minerals sector and ensuring continued government support.

TrivarX Limited has announced the acquisition of Stabl-Im, a novel stable isotope MRI technology for early brain tumor detection, backed by a $4.2 million capital raise including investment from biotech leader Dr Daniel Tillett.

Biotron Limited is set to acquire Sedarex Limited, gaining global patents for SedRx, a next-generation general anaesthetic, supported by a $2.5 million capital raising to fund regulatory and development milestones.

Artrya Limited has successfully navigated a key FDA Q-Submission meeting, receiving clear guidance on the regulatory pathway for its Salix Coronary Flow module, with a 510(k) submission planned by year-end.

Imagion Biosystems has completed manufacturing its MagSense® HER2 imaging agent, progressing toward a Phase 2 clinical trial with strong collaborations and a recent AU$3.5 million capital raise.

Micro-X has completed its first Head CT test bench, marking a key milestone as it begins pivotal imaging trials in Australian hospitals to revolutionize stroke diagnosis.