Latest Fda News

Genetic Signatures reported a 63% revenue increase to $15.9 million in FY25, alongside a 28% reduction in underlying losses and a strategic shift in its automated diagnostics platform development.

Genetic Signatures Limited reported a 63% revenue surge to $15.9 million in FY25, driven by strong Australian sales and progress in EMEA, while navigating a $20.1 million net loss and a strategic pivot towards partnerships for automated diagnostics.

Arovella Therapeutics reported a 14% reduction in net loss to $7.5 million for FY25, bolstered by a $15 million capital raise to fund its lead iNKT cell therapy program progressing toward a pivotal phase 1 clinical trial.

Australian Vintage reported a slight sales dip in FY25 but improved earnings and cash flow, setting the stage for a transformational FY26 driven by innovative brands and strategic expansion.

Atomo Diagnostics reports a significant expansion in its supply agreement with Lumos for the Pascal test cassette, tied to the promising CLIA waiver status of the FebriDx test in the US. This deal could nearly double Atomo’s revenues over the next three years.

Telix Pharmaceuticals reported a robust 63% year-over-year revenue increase in H1 2025, driven by strong sales of its precision medicine products and strategic acquisitions. The company is advancing multiple late-stage clinical trials and expanding its global manufacturing footprint.

Artrya Limited has secured FDA 510(k) clearance for its Salix Coronary Plaque module, enabling near real-time detection of high-risk coronary artery plaque and opening a lucrative U.S. market opportunity with a $950 reimbursement per scan.

Artrya Limited reported a 17.2% increase in net loss to $16.4 million for FY25, while achieving FDA clearance and launching its AI-driven Salix platform in the U.S. market. The company also secured key commercial partnerships in Australia and raised $20 million in equity funding.

Prescient Therapeutics reported an 11.1% reduction in net loss for FY2025, progressing its lead candidate PTX-100 into Phase 2a trials with FDA Fast Track and Orphan Drug designations, supported by a recent $9.8 million capital raise.

Invion Limited secures a pivotal FDA Orphan Drug Designation for its lead candidate INV043, targeting anal cancer with promising preclinical results and a fast-tracked development path.

Invion Limited has disclosed that the US FDA granted Orphan Drug Designation for its lead cancer drug candidate INV043, explaining recent unusual trading activity in its shares. The company confirmed it was unaware of the FDA decision prior to its public release and has now complied with continuous disclosure rules.

Neurizon Therapeutics reports encouraging topline results from its Phase 1 Open-Label Extension study of NUZ-001, demonstrating long-term safety and a significant survival advantage in ALS patients. These findings pave the way for the pivotal HEALEY ALS Platform Trial planned for late 2025.