Latest Regulatory Strategy News

Nyrada has dosed the first patient in its Phase IIa trial of Xolatryp targeting heart attack recovery, while strengthening its cash reserves and receiving a US patent allowance for its lead drug.

Ceretas Limited is raising $8 million through an IPO to fund clinical trials and development of its novel therapeutic ultrasound device targeting Alzheimer’s disease symptoms.

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.

Island Pharmaceuticals has secured a critical collaboration with Texas Biomedical Research Institute to advance dose optimisation for its antiviral Galidesivir, targeting Marburg Virus Disease under the FDA Animal Rule. This second phase complements ongoing USAMRIID efforts and aims to de-risk pivotal study design with data from 32 non-human primates.

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Peter Warren Automotive has withdrawn its initial ACCC application for the Wakeling Automotive acquisition, opting to submit a fresh Phase 1 proposal with remedies to secure regulatory approval.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