Latest Regulatory Affairs News

Telix Pharmaceuticals delivered a strong 56% revenue increase in 2025, driven by U.S. sales of Illuccix and the launch of Gozellix, while advancing its therapeutic pipeline and expanding global manufacturing capabilities. Despite a net loss, the company is investing heavily in R&D and sustainability initiatives aligned with climate-related disclosures.

Cleo Diagnostics has chosen Bio-Techne’s next-generation Ella™ platform to enhance its ovarian cancer blood test, aiming for faster, more precise results and a streamlined path to FDA approval.

Aurizon Holdings reported a 9% rise in underlying EBITDA to $891 million for the half-year ending December 2025, driven by higher volumes and yields in coal and bulk segments. The company also raised its full-year dividend guidance and extended its share buy-back program.

Celsius Resources has secured a Supreme Court order validating its auditor appointment and prior share issues, paving the way for its shares to be reinstated on the ASX.

Algorae Pharmaceuticals has secured a key Licence & Supply Agreement with Cadila Pharmaceuticals to commercialise two generic cardiovascular and metabolic medicines in Australia and New Zealand, broadening its therapeutic reach beyond oncology.

Neuren Pharmaceuticals has received detailed feedback from the US FDA on its clinical development plans for NNZ-2591 targeting hypoxic ischemic encephalopathy and Pitt Hopkins syndrome, paving a clearer path forward despite some delays.

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.