Latest Regulatory Affairs News

Island Pharmaceuticals secures FDA confirmation on Galidesivir’s development under the Animal Rule, unlocking a streamlined two-stage approval process and significant commercial incentives.

Acadia Pharmaceuticals has received a negative vote from the European Medicines Agency’s committee on its application to market trofinetide for Rett syndrome in the EU, prompting plans for a re-examination request.

Argenica Therapeutics has won a crucial regulatory waiver from the European Medicines Agency, removing the need for paediatric trials for its stroke drug ARG-007 and clearing the way for faster adult market approval in Europe.

Tissue Repair’s December quarter update reveals a cautious path forward for its Phase 3 TR987 trial amid slow patient recruitment, while its TR Pro+ product line gains momentum through a new distributor partnership and upcoming product launches.

Clarity Pharmaceuticals reports robust progress in prostate cancer and neuroendocrine tumour trials alongside a strong cash position of $226.2 million, underpinning its path towards commercialisation.

Alterity Therapeutics has bolstered its Phase 2 data for ATH434 in Multiple System Atrophy and is advancing regulatory plans for a pivotal Phase 3 trial, supported by a robust cash position of A$49.2 million.

Imugene Limited has reported compelling clinical trial results for its off-the-shelf CAR T therapy, azer-cel, alongside FDA validation and a strategic collaboration, while managing cash flow amid cost reductions.

Optiscan Imaging Ltd has made significant strides in clinical studies and regulatory readiness, partnering with Australian Clinical Labs and launching new cancer imaging trials as it prepares for multiple FDA submissions in 2026.

Besra Gold Inc has updated its Bau Gold Project resource estimate and is intensifying efforts to secure critical mining lease renewals, while restructuring its operations to sharpen capital discipline and technical oversight.

BlinkLab Limited has delivered strong diagnostic results in its U.S. autism pilot study, exceeding FDA performance thresholds and setting the stage for a pivotal 510(k) trial. The company also expanded its clinical trial network and nears completion of its European ADHD study.

Amplia Therapeutics reports encouraging clinical progress for its pancreatic cancer drug narmafotinib, with a 35% confirmed response rate in the ACCENT trial and FDA support for dose optimisation. The company also uplisted to the US OTCQB market and secured a key patent extending protection to 2040.

Evolution Energy Minerals has ramped up exploration at its Chikundo Copper Project while stabilising its finances and navigating regulatory hurdles in Tanzania. The company is preparing for drilling in 2026 despite a tight cash position.