Latest Manufacturing Milestones News

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.

EBR Systems’ new Santa Clara manufacturing facility has entered the FDA’s pre-approval inspection process, marking a key regulatory step for its wireless cardiac pacing business. The company continues to expect approval by the end of 2026, but the inspection does not yet amount to clearance.

EBR Systems has secured ISO 13485 certification for its new Santa Clara manufacturing site, paving the way for a 500% increase in WiSE System production pending FDA approval expected by year-end.

Cleo Diagnostics has received its first commercial batch of ovarian cancer test kits from Bio-Techne, marking the start of analytical validation critical for its FDA submission planned in early 2027.

Patrys Limited is pushing forward with a proprietary injectable formulation of quetiapine targeting the lucrative delirium treatment market, leveraging a faster, lower-cost FDA 505(b)(2) regulatory pathway and strong patent protection.

dorsaVi has moved from design to silicon manufacturing with the tape-out of its first 22-nm RRAM-CMOS validation chip, aiming to prove its advanced memory platform for AI and robotics applications.

Patrys has assigned its deoxymab intellectual property to Yale University in a deal granting it half of all future commercialisation revenue, reducing capital needs while keeping long-term upside.

AdAlta has met a key US$1 million milestone payment under its China collaboration, gaining critical clinical data and securing proprietary materials for Australian manufacturing of its lead CAR-T therapy BZDS1901.

Aurora Labs has begun batch deliveries of its AU4 micro gas turbine propulsion systems to Sovereign Propulsion Systems, marking a key step towards real-world flight testing and commercialisation in defence and UAV markets.

Critical Resources has scaled its solid-state battery program from coin cells to full-format pouch cells, marking a key manufacturing milestone with electrochemical testing now underway. The next phase aims to integrate its proprietary sulphur-free solid-state electrolyte into these cells.

Island Pharmaceuticals is accelerating development of its broad-spectrum antiviral Galidesivir, progressing clinical, regulatory, and manufacturing milestones under the FDA Animal Rule pathway with expanded USAMRIID collaboration and biodefence positioning.

Island Pharmaceuticals has kicked off GMP manufacturing of its antiviral Galidesivir to support late-stage Marburg virus studies under the FDA Animal Rule, marking a key step towards regulatory submission and biodefence readiness.