Latest Fda News

Recce Pharmaceuticals has won a significant Australian Government R&D tax incentive, unlocking up to A$85 million for its synthetic anti-infective programs worldwide, including a pivotal Phase 3 clinical trial.

Adherium Limited reports a remarkable 103% quarter-on-quarter growth in Remote Patient Monitoring subscription revenues for Q2 FY26, driven by strong device shipment momentum and strategic operational changes.

Immutep Limited reports robust progress in its pivotal Phase III TACTI-004 trial for advanced non-small cell lung cancer, with over 120 clinical sites activated across 27 countries including the US. Patient enrolment has reached 38% of the target, keeping key milestones on track.

Radiopharm Theranostics reports promising interim Phase 2b results for RAD 101, achieving 92% concordance with MRI in detecting brain metastases, paving the way for a pivotal study in 2026.

Prescient Therapeutics has secured European authorization to initiate a Phase 2a clinical trial of its novel cancer drug PTX-100 for relapsed/refractory Cutaneous T-cell Lymphoma, enabling trial site activation in Italy.

Cynata Therapeutics has finalised patient enrolment in its pivotal Phase 2 trial of CYP-001 for acute graft versus host disease, setting the stage for critical data due mid-2026.

Neuren Pharmaceuticals’ partner Acadia secures FDA approval for DAYBUE STIX, a new powder formulation of trofinetide offering greater flexibility for Rett syndrome patients. This milestone expands treatment options and sets the stage for increased royalty revenue in 2026.

Dimerix has successfully completed recruitment and dosing of 286 adult patients in its Phase 3 ACTION3 trial evaluating DMX-200 for focal segmental glomerulosclerosis (FSGS), advancing toward regulatory discussions with the FDA.

Imricor Medical Systems has secured Institutional Review Board approval for the University of Virginia Health to join its VISABL-AFL clinical trial, marking a key expansion in the US. Procedures are set to begin early next year, supporting Imricor’s progress toward FDA approval and commercialisation.

Echo IQ has formally lodged its FDA 510(k) submission for EchoSolv HF, an AI-driven heart failure diagnostic software validated by Mayo Clinic data, aiming to tap into a $60 billion US market.

An independent meta-analysis presented at the ASH Annual Meeting reveals Mesoblast’s remestemcel-L achieves superior remission rates and safety outcomes compared to ruxolitinib in treating steroid-refractory acute graft-versus-host disease.

4DMedical has locked in $30.2 million through an underwriting agreement ensuring full exercise of its listed options, lifting its cash reserves to $63.7 million and setting the stage for a pivotal year in commercialising its CT – VQ™ technology.