Latest Regulatory Affairs News

Infinity Lithium progresses its Australian gold-copper-silver exploration with new option agreements, while facing delays and strategic shifts in its Spanish lithium project.

Cleo Diagnostics reports steady progress in its ovarian cancer diagnostic test development, with clinical trial recruitment on track and strategic access to major biobanks enhancing its regulatory pathway.

Mesoblast has reported a strong commercial debut for Ryoncil, the first FDA-approved mesenchymal stromal cell therapy for pediatric steroid-refractory acute graft-versus-host disease, generating US$13.2 million in gross revenue in its initial quarter. The company is advancing regulatory and clinical milestones while expanding insurance coverage across the US.

BPH Global Ltd (ASX, BP8) has initiated strategic discussions with Indonesia’s National Economic Council to deploy its innovative seaweed-based bioremediation solutions targeting pollution from nickel and coal mining operations.

Imagion Biosystems has received encouraging feedback from the FDA on its MagSense HER2 breast cancer imaging program, clearing the path for a Phase 2 clinical trial and fast-tracking manufacturing.

Imugene Limited reports promising Phase 1b trial results for azer-cel, an off-the-shelf CAR T therapy, showing a 75% overall response rate in relapsed diffuse large B-cell lymphoma patients. The company plans to engage the FDA later this year to discuss pivotal trial design.

Imagion Biosystems has received encouraging feedback from the FDA on its planned Phase 2 HER2 breast cancer clinical trial, paving the way for its Investigational New Drug application submission later this year.

Neurizon Therapeutics has received positive feedback from the FDA on its plan to resolve the clinical hold on its ALS drug candidate NUZ-001, with key preclinical studies completed ahead of schedule. The company aims to resume clinical trials in late 2025.

Argent BioPharma has begun supplying its EU-GMP cannabinoid API for drug-resistant epilepsy treatment at University Medical Centre Ljubljana, marking a key clinical and regulatory milestone in Europe.

BlinkLab has expanded its pivotal FDA autism diagnostic trial by adding the University of Nebraska Medical Center as a second U.S. clinical site, advancing toward broader validation and regulatory clearance.

Marvel Gold Limited has extended the completion date for the sale of its Mali gold projects to August 2025 due to ongoing regulatory delays, signaling cautious navigation of complex local approvals.

Prescient Therapeutics has opened a Share Purchase Plan to raise up to $7 million, offering shareholders discounted shares to fund the Phase 2 development of its targeted cancer therapy PTX-100.