Latest Safety News

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.

Orthocell has lodged a regulatory application to distribute its nerve repair product Remplir™ across the EU and UK, aiming to tap into a $750 million market with approval expected by Q3 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.

Blue Star Helium has completed mechanical assembly of its Galactica helium facility and is set to begin commissioning this week, aiming for first production by December 2025.

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.

GenusPlus Group, partnering with ACCIONA, has won a $1.6 billion contract to build Victoria’s Western Renewables Link, a major transmission project set to power up to one million homes with renewable energy.

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.

HITIQ has secured a prestigious grant from the Australian Sports Commission to enhance its PROTEQT™ brain health monitoring technology, positioning the company for wider adoption across elite and community sports.

EBR Systems has completed the first patient implant in its Totally Leadless CRT (TLC-AU) feasibility study, marking a strategic step toward expanding wireless cardiac resynchronisation therapy for heart failure patients.

Boom Logistics has appointed Lester Fernandez as its permanent Managing Director and CEO, entrusting him to lead the company through its next phase of growth with a strong focus on safety and operational excellence.