Latest Regulatory Milestones News

Optiscan Imaging has kicked off a US clinical trial with Mayo Clinic to test its InVue and InForm devices in breast conserving surgery, aiming to generate data for FDA 510(k) submissions and validate a new surgical-pathology workflow.

Coda Minerals has cleared a key regulatory hurdle for its Elizabeth Creek Copper-Silver Project with the formal gazettal of its Scoping Report, setting a clear pathway for mining lease approval and reducing project uncertainty.

AFT Pharmaceuticals secures tentative FDA approval for Scomara cream to treat rare facial tumours but faces a US launch delay due to orphan drug exclusivity. The approval bolsters prospects in other markets where AFT expects competitive advantages.

Telix Pharmaceuticals reported a 21% year-on-year revenue jump to US$247 million in Q2 2026, buoyed by strong Precision Medicine sales and a new Regeneron partnership. The company also secured FDA alignment on a pivotal prostate cancer trial and expanded its manufacturing footprint.

Vysarn Limited reported a record FY26 with NPBT of $20.9 million and operational revenue of $140.1 million, while completing the $50 million NewGround acquisition that boosts pro forma EPS by 26.7%.

Ausgold Limited has cleared significant regulatory hurdles for its Katanning Gold Project, with Western Australia’s EPA approving the Environmental Review Document for public release and three new mining leases granted, paving the way for a final investment decision by late 2026.

Richmond Vanadium Technology has appointed Seth McCann as General Manager for Development, Approvals & Studies, positioning the company to advance critical environmental and regulatory milestones for its Queensland vanadium project.

Memphasys delivered a record $150,000 quarterly revenue, secured its largest Felix™ supply contract with Monash IVF, and expanded into UK and Southeast Asian IVF markets, positioning for accelerated growth in FY27.

Neurotech International has locked in a $3.15 million secured loan against its anticipated R&D tax incentives to fund pivotal Phase III autism trials and ongoing operations.

Phoslock Environmental Technologies increased production significantly in the June quarter but faced a higher operating cash flow deficit and ongoing legal disputes.

Neurotech International has secured FDA clearance for its Investigational New Drug application for NTI164, enabling clinical development in the US and advancing its global registration and commercialisation plans.

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.