Latest Fda News

Imagion Biosystems has progressed its MagSense HER2 breast cancer imaging agent towards a pivotal Investigational New Drug application with the FDA, backed by a solid funding runway exceeding 13 quarters.

Dimerix Limited advances its Phase 3 kidney disease trial with FDA acceptance of proteinuria as a primary endpoint and clinches a lucrative licensing agreement in Japan worth up to AU$107 million plus royalties.

TrivarX has launched a pivotal mental health clinical trial in partnership with the US Department of Veterans Affairs, leveraging its innovative ECG-based technology to screen for major depressive episodes. The company also secured $2.25 million in funding, positioning it for regulatory milestones ahead.

Mesoblast has commercially launched Ryoncil in the US for pediatric acute GVHD, backed by a strong cash position and advancing multiple cell therapy programs.

Genetic Signatures Ltd reported a robust 71% jump in quarterly sales to $2.9 million, fueled by strong respiratory testing demand in Australia and key US commercial contracts. The company is advancing its automation and instrument customisation strategy to streamline molecular diagnostics offerings.

Hydrix Limited reports improved operating performance in Q3 FY25, buoyed by FDA clearance of its Gyder Surgical Hip Navigation system and a reduced cash operating loss, while managing tight liquidity with shareholder support.

dorsaVi’s Q3 FY25 report reveals growing adoption of its AI-powered video movement analysis in the US, a new elite athlete research partnership, and the launch of a pioneering 3D ACL injury prevention test.

Tissue Repair Limited reports progress in its Phase 3 clinical trials for TR987® despite enrollment delays caused by US regulatory disruptions, while TR Pro+® sales hit record highs and manufacturing scale-up advances.

Starpharma reports steady progress in its DEP® drug development programs, launches new marketing campaigns in key regions, and maintains a strong cash position of $17.2 million as it refines clinical strategies and partnerships.

Adherium Limited reports a surge in US commercial patients for its Hailie Smartinhaler platform, alongside strategic hires and a new product launch compatible with AstraZeneca inhalers, underpinning plans for a capital raise.

INOVIQ Limited reports significant progress in its exosome-based cancer diagnostics and therapeutics, including expanded customer adoption, advanced AI screening tests, and strategic partnerships with leading research centres.

Optiscan Imaging Ltd has revealed its next-generation InForm™ pathology imaging device and strengthened its executive team, while reporting a robust cash position supported by a $1.775 million R&D tax refund for the quarter ended 31 March 2025.