Latest Patient Safety News

Nyrada has secured AU$12.0 million from institutional and sophisticated investors, with a further AU$2.0 million shareholder purchase plan planned, giving the biotech funding to advance its Xolatryp clinical programs. The raise also carries substantial dilution and an unusually large proposed director subscription worth AU$5.125 million, subject to shareholder approval.

Emyria has presented its regulated Australian psychedelic-treatment experience to the US FDA, putting clinical delivery systems rather than drug development at the centre of its US ambitions. The appearance raises the company’s profile, but does not yet disclose regulatory approval, a commercial agreement or a financial commitment.

EBR Systems plans to file a Changes Being Effected PMA supplement in the fourth quarter to make echo-induced pacing risks and their mitigations more prominent on WiSE System labelling. The FDA has aligned with the proposed path, but the filing and final labelling changes are still ahead.

Emyria has secured a limited in-person speaking position at a US FDA hearing examining how psychedelic medicines could be delivered safely and at scale. The appearance gives the ASX-listed company a regulatory platform, but does not represent FDA approval, funding or a commercial agreement.

Clever Culture Systems secures a follow-up order from Novo Nordisk for two APAS Independence instruments, marking a critical step toward broader global deployment and signalling expected sales growth from FY27.

Racura Oncology has launched patient enrolment at its first Korean site for the CPACS Phase 1 trial, aiming to accelerate recruitment and validate RC220’s safety and efficacy in a key oncology market.

Imricor Medical Systems has officially launched its US commercial operations, securing Rady Children’s Hospital–San Diego as the first customer for its NorthStar iMR mapping system, following key FDA clearances including pediatric approvals.

OncoSil Medical’s interim OSPREY Registry data show strong safety and promising survival outcomes for its targeted radiotherapy device in unresectable locally advanced pancreatic cancer, surpassing historical benchmarks.

Racura Oncology reported robust progress in Q3 FY2026, including launching a key lung cancer trial and unveiling a novel blood test for cardioprotection, supported by a solid $19.38 million cash position.

Radiopharm Theranostics has received a positive recommendation to escalate the dose of its 177Lu-RAD202 radiotherapeutic in a Phase 1 trial targeting HER2-positive advanced solid tumors, maintaining its timeline to complete dose escalation by year-end 2026.

Racura Oncology has enrolled the first patient in its Phase 1 HARNESS-1 trial, testing RC220 alongside osimertinib to tackle resistance in EGFR-mutant non-small cell lung cancer. This milestone sets the stage for a multi-centre study aiming to improve treatment outcomes.

Racura Oncology has secured governance approval to launch its Phase 1 HARNESS-1 trial, testing RC220 alongside osimertinib in EGFR-mutated non-small cell lung cancer patients. This milestone sets the stage for a potentially pivotal new approach to overcoming resistance in lung cancer treatment.