Latest Regulatory Strategy News

Entropy Neurodynamics has partnered with BioCina to establish GMP manufacturing for its intravenous psilocin formulation TRP-8803, a critical step toward late-stage clinical trials and commercialisation.

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.

Control Bionics has achieved FDA registration for its NeuroStrip surface EMG platform, cementing its medical device status in the US and bolstering its appeal in clinical and research markets.

Neurotech International has secured FDA clearance for its NTI164 Investigational New Drug application and obtained Notices of Allowance for two US patents, advancing its Phase 3 autism spectrum disorder program.

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.

Clinuvel Pharmaceuticals targets year-end for topline results from its pivotal vitiligo trial of SCENESSE® combined with narrowband UVB, aiming to expand the drug's use beyond its current rare disease indication.

Prescient Therapeutics boosted enrolment in its PTX-100 Phase 2a trial to 28 patients and appointed Dr Rosalind Wilson as Chief Medical Officer, strengthening its clinical leadership as it advances targeted cancer therapies.

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.