Latest Regulatory Pathways News

Bioxyne Limited is expanding its footprint with a new UK GMP-certified medicinal cannabis manufacturing site, backed by £850,000 in funding from South of Scotland Enterprise. This move positions the company to tap into the UK’s growing medicinal cannabis market, the second largest in Europe.

PYC Therapeutics reports sustained vision improvements in patients with Retinitis Pigmentosa type 11 treated with VP-001, showing promising safety and efficacy up to 18 months. The company plans to engage the FDA in early 2026 to finalize pivotal trial design.

Island Pharmaceuticals will host a webinar to discuss the FDA's feedback on the clinical development and regulatory approval of its antiviral drug Galidesivir, including key considerations under the FDA's Animal Rule and Priority Review Voucher eligibility.

Anteris Technologies Global Corp. reported a $22.2 million loss in Q3 2025 while progressing its DurAVR Transcatheter Heart Valve pivotal trial following key regulatory approvals. The company bolstered its cash position with a $25.2 million private placement post-quarter.

Optiscan Imaging has entered a three-year strategic collaboration with Australian Clinical Labs to validate and deploy its InForm™ digital pathology platform, aiming to transform diagnostic workflows with real-time tissue analysis.

Monash University has secured a $799,866 Australian Research Council grant to study brain injury thresholds using HITIQ’s PROTEQT™ instrumented mouthguards, with a $200,000 pre-order confirming commercial momentum.

Mesoblast is set to meet the FDA in December to discuss compelling Phase 3 data showing its cell therapy rexlemestrocel-L may significantly reduce opioid use in chronic low back pain patients. This meeting could mark a pivotal step in addressing the US opioid crisis through innovative regenerative medicine.

Far East Gold has secured a pivotal PIPPIB approval for 9,000 hectares of its Idenburg Gold Project in Papua, Indonesia, clearing a major regulatory hurdle and accelerating its path toward mine development.

TrivarX Limited has exercised its option to acquire the innovative Stabl-Im brain imaging technology, aiming to revolutionize early detection of brain tumours pending shareholder approval.

Anteris Technologies has secured FDA approval to commence its pivotal PARADIGM clinical trial, testing its innovative DurAVR Transcatheter Heart Valve against established devices in patients with severe aortic stenosis.

Santana Minerals has lodged a comprehensive Fast-track Approvals application for its Bendigo-Ophir Gold Project in New Zealand, aiming for development consents by the end of the 2026 financial year. The project promises significant economic and employment benefits for the Central Otago region.

InhaleRx has secured FDA alignment and ethics approvals to progress clinical trials for its inhaled therapies targeting breakthrough cancer pain and panic disorder, with patient dosing set to begin soon.