Latest Regulatory Strategy News

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.

OncoSil Medical has submitted its Humanitarian Device Exemption application to the FDA for its OncoSil™ device targeting distal cholangiocarcinoma, entering the final review phase with a decision expected within 45 days.

Recce Pharmaceuticals has secured ethics approval to upgrade and broaden its pivotal Phase 3 trial of RECCE® 327 Topical Gel for diabetic foot infections in Australia, accelerating recruitment and reinforcing its global registration ambitions.

Peter Warren Automotive has withdrawn its initial ACCC application for the Wakeling Automotive acquisition, opting to submit a fresh Phase 1 proposal with remedies to secure regulatory approval.

Island Pharmaceuticals is accelerating development of its broad-spectrum antiviral Galidesivir, progressing clinical, regulatory, and manufacturing milestones under the FDA Animal Rule pathway with expanded USAMRIID collaboration and biodefence positioning.

Imricor Medical Systems has submitted the third of four Premarket Approval modules to the FDA, marking a key step towards US approval of its MR-guided cardiac ablation devices.

Noxopharm has unveiled new data showing its Sofra technology dramatically boosts TLR8 activation, a key immune pathway, potentially reshaping cancer immunotherapy.

TrivarX has contracted Beyond Drug Development to drive its Stabl-Im MRI imaging platform into Phase 1 trials, aiming to start safety testing in healthy volunteers by late 2026.

OncoSil Medical has clinched TGA approval for its OncoSil™ device, the first Class III medical device targeting pancreatic tumours in Australia, paving the way for local commercialisation and enhanced patient access.

BPH Global inks binding deal with Temasek Innovation Holdings to validate its seaweed-based male vitality product through targeted biological assays, advancing regulatory and commercial ambitions.

Noxopharm is gearing up for a pivotal pre-IND meeting with the US FDA, enlisting global CRO Novotech to sharpen its regulatory approach for SOF-SKN, a drug targeting autoimmune skin diseases.

NeuroScientific Biopharmaceuticals reported positive clinical responses in its StemSmart™ Special Access Program for fistulising Crohn’s disease and has initiated manufacturing technology transfer to support Phase 2 trials planned for late 2026.