Latest Regulatory Affairs News

EMVision Medical Devices has hit key enrolment milestones in its pivotal brain scanner trial, expanded clinical endpoints, and maintained a strong cash position with $17.1 million on hand.

Vectus Biosystems has appointed Cardinal Health Regulatory Services as its US regulatory agent to manage FDA submissions for its lead fibrosis drug VB0004, marking a pivotal step towards clinical development in the US.

Dimerix will provide continued access to its investigational drug DMX-200 for eligible patients with focal segmental glomerular sclerosis after completing the pivotal ACTION3 Phase 3 trial, supporting ongoing treatment ahead of regulatory approval.

Island Pharmaceuticals is progressing its broad-spectrum antiviral Galidesivir amid a severe Ebola outbreak, securing government approvals in Uganda and outlining a dual clinical and regulatory development pathway targeting multiple deadly filoviruses.

Noxopharm has taken a key regulatory step by requesting a pre-IND meeting with the US FDA for its autoimmune drug candidate SOF-SKN, aiming to smooth the path for clinical development and boost its commercial appeal.

Echo IQ has raised approximately A$110 million through a heavily supported institutional placement to fund its US commercial rollout and speed up development of its AI-driven cardiovascular diagnostics.

AdAlta has met a key US$1 million milestone payment under its China collaboration, gaining critical clinical data and securing proprietary materials for Australian manufacturing of its lead CAR-T therapy BZDS1901.

Neurizon Therapeutics has secured a critical five-year supply agreement with Elanco Animal Health for GMP-grade monepantel, underpinning the commercialisation readiness of its lead ALS drug candidate NUZ-001.

Island Pharmaceuticals has presented encouraging Phase 2a results for its dengue antiviral ISLA-101, demonstrating safety, effective blood concentrations, and meaningful viral load reductions at the Asia Dengue Summit.

Echo IQ has partnered with Mayo Clinic to assess its AI platform's ability to predict heart failure risk in patients undergoing cancer therapy, targeting the growing cardio-oncology sector.

Emyria Limited is progressing its national network of psychedelic-assisted therapy clinics, reporting durable patient outcomes, expanding funding sources, and benefiting from regulatory changes that broaden therapist eligibility.

Argenica has completed the last FDA-mandated cardiac safety assay for its stroke drug ARG-007, paving the way to lift the clinical hold and initiate Phase 2b trials in the US.