Latest Healthcare News

The US Centers for Medicare & Medicaid Services has recommended a final reimbursement price of US$1,328 for Pacific Edge’s advanced bladder cancer diagnostic test, Cxbladder Triage Plus, marking a significant increase from earlier proposals.

Artrya Limited has raised A$75 million through a two-tranche placement and launched a A$5 million share purchase plan to fast-track the U.S. commercialisation of its AI-powered Salix platform following FDA clearance.

Proteomics International Laboratories announces the planned retirement of its founder and Managing Director, Dr Richard Lipscombe, in February 2026, marking a pivotal leadership transition as the company seeks a new CEO to drive its next growth phase.

Telix Pharmaceuticals has secured FDA agreement on a resubmission plan for its glioma imaging agent TLX101-CDx, aiming for a Q4 2025 filing that includes additional efficacy data. The FDA signals likely expedited review, underscoring the unmet medical need.

Cann Group Limited has disclosed a late payment of over $1.37 million in interest and facility fees to National Australia Bank, which has issued a non-waiver letter but is holding off on immediate action. The company is actively negotiating financing arrangements and plans to update the market by the end of September 2025.

Alterity Therapeutics has raised A$20 million through a strategic placement to advance its promising ATH434 treatment for Multiple System Atrophy, backed by encouraging Phase 2 trial results. The capital injection strengthens the company’s balance sheet as it prepares for regulatory discussions with the FDA.

Imagion Biosystems has reached key milestones in its MagSense® HER2 breast cancer imaging program, including starting manufacturing for its Phase 2 trial and launching an AI imaging protocol collaboration with Wayne State University.

Orthocell Limited reports an 81.1% overall treatment success rate from its Remplir Real World Evidence study, reinforcing the product’s safety and efficacy as it expands sales in the US and prepares regulatory submissions for the EU and UK.

Mayne Pharma has publicly refuted recent media claims about plans to close its Salisbury manufacturing site, clarifying its position amid ongoing regulatory scrutiny of its Scheme transaction with Cosette.

4DMedical has secured multi-year agreements to deploy its advanced lung imaging technology across Brazil and Australia, supporting national lung cancer screening programs and enhancing lung health diagnostics.

Proteomics International has unveiled new clinical data confirming its PromarkerEso blood test can accurately detect early stages of esophageal adenocarcinoma, potentially transforming screening for a cancer with poor prognosis.

Pathkey.AI’s TrialKey platform has demonstrated a 73% alignment with actual biotech trial outcomes, showing an average hypothetical share price gain of 76%, underscoring AI’s growing role in clinical trial prediction and biotech investing.