Latest Fda Regulatory News

Archer Materials has pinpointed a capillary blood collection method that matches venous samples in haemolysis levels, advancing its potassium Biosensor development towards integrated clinical testing.

Argent BioPharma's licensing partner Splash Beverage Group has launched the US veterinary development program for CannEpil®, targeting companion-animal oncology and chronic pain. Led by industry veteran Dr Hunter Land, the initiative follows a defined FDA regulatory pathway and could broaden CannEpil®’s commercial footprint beyond human neurology.

Lumos Diagnostics has landed a US$767,800 purchase order for its FebriDx rapid test from PHASE Scientific, marking a key step in commercialising its FDA-approved product ahead of the US flu season.

Zelira Therapeutics has raised nearly US$33 million into its HOPE® 1 special purpose vehicle, valuing the SPV at about US$66 million post-money. The funds will advance FDA regulatory submissions and Phase 1 clinical trials for its autism-targeting cannabinoid drug.

Actinogen Medical’s pivotal XanaMIA Alzheimer’s trial stays on track for November topline results, buoyed by strong open-label extension enrolment and aligned EMA-FDA regulatory advice. A new antidepressant study publication and fresh patents add momentum, supported by a $16.7 million cash runway to mid-2027.

CONNEQT Health's June quarter saw record consumer revenue growth and a 70% jump in enterprise subscription ARR, supported by a $5.5 million placement and progress on its FDA regulatory pathway for its cloud-based vascular analytics platform.

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.

Orthocell Ltd delivered a standout FY26 with 44% revenue growth to A$13.2 million, powered by accelerating US sales of its nerve repair product Remplir and a robust cash position supporting further expansion.

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.

Alterity Therapeutics has secured official FDA confirmation that a single pivotal Phase 3 trial, backed by prior Phase 2 data, can support approval of ATH434 for Multiple System Atrophy. Trial initiation remains on track for late 2026.

Memphasys has locked in a three-year exclusive distribution agreement for its Felix™ sperm separation system in Thailand, targeting a key IVF market with 110 clinics and 20,000–30,000 cycles annually. The deal adds approximately A$430,500 in contracted revenue, lifting South-East Asian minimum contracts to about A$1 million and contributing to FY2026 Felix™ sales now exceeding A$3 million.

AdAlta has engaged specialist advisors to streamline US FDA regulatory processes for its CAR-T therapy BZDS1901, which has shown rare complete tumour clearance in advanced mesothelioma patients.