Latest Regulatory Affairs News

Firebrick Pharma expanded its patent portfolio with grants in Canada and New Zealand while achieving 43% sales growth in FY26 despite steady operating expenses. The company is advancing Nasodine's commercial rollout across Southeast Asia and the US.

Syntara secured positive FDA feedback for its Phase 2b amsulostat trial in myelofibrosis and raised $8 million to extend its cash runway to Q3 2027, while preliminary data showed promising brain inflammation reduction in a Parkinson’s-related disorder.

Argenica Therapeutics is gearing up for a pivotal late-stage clinical trial of its neuroprotective drug ARG-007 (xaranetide) in acute ischaemic stroke, backed by strong safety assays and solid funding.

Biotron has received pivotal regulatory feedback from the European Medicines Agency ruling out a Hybrid Marketing Authorisation for SedRx, prompting plans for pivotal clinical trials. The company also advances its lead antiviral candidate BIT-HBV001 against Hepatitis Delta Virus and appoints a new chairman.

Optiscan Imaging has fast-tracked Stage 2 of its pioneering head and neck cancer imaging study, moving into live intraoperative imaging ahead of schedule. This advancement supports FDA regulatory efforts and enhances the company’s AI imaging development.

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.