Latest Manufacturing Quality News

Mesoblast has secured FDA approval to add a new potency assay to commercial release and stability testing for Ryoncil, its approved cell therapy for paediatric graft-versus-host disease. The regulatory decision supports tighter monitoring as manufacturing processes evolve, but the company disclosed no direct financial impact or clinical outcome data.

The Calmer Co. has signed a binding heads of agreement with Kaiming Agro Processing to establish a long-term manufacturing partnership, leveraging advanced extraction technology in Fiji to scale its premium botanical ingredients business globally.

AdAlta has secured Australian manufacturing for its lead CAR-T therapy BZDS1901, which has shown rare complete tumour clearance in advanced mesothelioma patients. This move is a key step toward local clinical trials and boosts the therapy’s global commercial appeal.

IDT Australia is poised for its strongest FY26 finish since its transformation began, forecasting a dramatic narrowing of EBITDA losses and revenue growth driven by strategic partnerships and operational upgrades.

Imagion Biosystems has submitted its Investigational New Drug application to the U.S. FDA for its MagSense® HER2 Imaging Agent, marking a pivotal step toward launching a Phase 2 clinical trial for breast cancer detection.

Argent BioPharma has secured a transformative acquisition of AusCann’s core assets, bolstering its drug delivery technology and manufacturing capabilities ahead of a planned U.S. listing. The company also reported key clinical milestones and refinancing moves in its September 2025 quarterly update.

Matrix Composites & Engineering has landed a new A$10 million subsea buoyancy contract for a Gulf of Mexico project, adding to over A$45 million in awards this financial year and reinforcing its global SURF market presence.

Osteopore Limited reports a three-fold increase in craniofacial implant sales within a year of signing an exclusive distribution deal with Zimmer Biomet, signaling strong early traction across key global markets.