Latest Us Fda News

AdAlta has secured a formal US FDA pre-IND meeting for EW-001, moving its mesothelioma CAR-T therapy into a critical regulatory review. The November meeting will test the company’s Australian manufacturing, remaining studies and proposed Phase 1 trial before the more expensive stages of development begin.

Echo IQ says it sees a path to US FDA clearance for EchoSolv HF after receiving a Not Substantially Equivalent determination. The company is weighing an appeal, an Ombudsman review or a fresh 510(k) submission, but has not selected a route or set a firm timetable.

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’ 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.

Bubs Australia has secured permanent US FDA authorisation for three infant formula products, removing a regulatory barrier in the company’s largest market. The approval supports possible portfolio expansion and contract manufacturing, but the presentation contains no new earnings guidance or quantified financial benefit.

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.

AdAlta’s partner SHcell has gained regulatory approval to provide the BZDS1901 CAR-T therapy to advanced mesothelioma patients in China’s Hainan Boao Lecheng special access zone, marking a key milestone in real-world data collection and treatment availability.

Ceretas Limited posted a $1.63 million net loss for FY26 on $1.28 million revenue from government grants, advancing its clinical-stage Alzheimer’s ultrasound platform. The company completed an $8 million IPO in July to fund pivotal trials and device development.

Vectus Biosystems has reported a striking turnaround with a $1.56 million profit for the 2026 financial year, reversing a prior year loss and improving its balance sheet significantly.

Clarity Pharmaceuticals reported a 67% increase in net loss to $107.2 million for FY26, driven by higher R&D spending, while advancing multiple Phase III trials and expanding manufacturing capacity ahead of commercialisation.

Acrux Limited reported a 46% revenue increase to $6.6 million in FY26, driven by US generic product royalties and licensing milestones, while narrowing its net loss by 90%. The company is pivoting towards developing a female testosterone therapy with encouraging Phase II data and active regulatory engagement.

Prescient Therapeutics (ASX:PTX) has opened a $7 million Share Purchase Plan at a significant discount to advance its lead cancer therapy PTX-100 beyond a pivotal Dose Optimisation Committee review in late 2026.