Latest Manufacturing News

Optiscan Imaging has lodged a US FDA 510(k) application for InVue, its precision surgery device designed to provide cellular-level imaging during operations. The submission moves the technology into formal regulatory review, but clearance and commercialisation remain uncertain.

Radiopharm says the FDA has provided a clear framework for the pivotal development of RAD101, its investigational brain metastases imaging agent. The company is preparing for Phase 3 while awaiting formal meeting minutes that could still refine the trial design and regulatory requirements.

Aurora Labs has appointed Andrew Garth as chief executive, moving former CEO Rebekah Letheby into a newly focused chief operating role. The reshuffle is intended to separate commercial strategy from technical execution as the company pursues scaled manufacturing and defence opportunities.

AdAlta and Shanghai Cell Therapy Group have approved the FDA briefing pack and manufacturing transfer plan for EW-001, bringing the mesothelioma CAR-T therapy closer to an Australian Phase 1 trial. The FDA meeting is scheduled for November, while two Chinese patients remain under follow-up, including a second complete responder.

First Graphene has signed a three-year agreement with Turkish manufacturer Aeropreg to develop and potentially commercialise PureGRAPH-enhanced carbon fibre prepreg. The partnership offers a clearer route into aerospace, defence and automotive supply chains, but commercial launch remains dependent on trial results.

6K Additive has completed a six-year, US$27.4 million secured loan with the US Export-Import Bank to expand production of critical metal powders in Pennsylvania. The financing gives the company access to project funding through June 2028, but the final interest rate and the expansion’s eventual output remain to be established.

Island Pharmaceuticals has begun GMP production of Galidesivir, with the first 5kg batch targeted for an investigational Ebola treatment program in Uganda. A second batch is intended to support a pivotal Marburg animal study under the FDA’s Animal Rule pathway.

Peter Warren Automotive has completed its acquisition of Wakeling Automotive, but the transaction remains tied to eight dealership divestments required by the ACCC. The deal expands Peter Warren’s dealership portfolio while leaving a significant regulatory obligation outstanding.

Aeris Environmental’s FY2026 annual report pairs international commercial progress with a $5.03 million operating cash drain, $9.22 million in net liabilities and an auditor-highlighted material uncertainty over its ability to continue as a going concern. The company says it will need extended related-party loan terms and further funding while converting its technology and chemicals pipeline into recurring revenue.

Optiscan Imaging has lodged a 510(k) submission for its InForm digital pathology device, moving the product from development into formal US regulatory assessment. FDA clearance is not assured, but a successful determination could open the door to commercial distribution in the company’s target market.

LTR Pharma has completed the final Phase II pharmacokinetic report for SPONTAN, confirming a median 10-minute time to peak concentration against 60 minutes for an oral vardenafil tablet. The result completes the FDA-aligned dataset ahead of planned US submission work, although efficacy in erectile dysfunction patients remains to be tested.

ClearVue Technologies reported just A$108,484 of FY2026 revenue against an A$11.86 million loss, while consuming A$8.69 million in operating cash. The solar-glazing developer says certifications, international partners and an 80-project pipeline have strengthened its platform, but the next test is converting those assets into cash revenue.