Latest Fda Approvals News

ReNerve’s October AGM presentation points to sharply higher sales, a growing US distribution network and a broader nerve repair pipeline. The company is also progressing a 240-patient NervAlign clinical study while relying on a $5 million RiverFort funding facility to support expansion.

Immuron delivered record FY26 sales, a narrower loss and a much stronger cash balance, while shifting clinical development towards commercial partners. The annual report also flags a material weakness in inventory controls and confirms that IMM-529 remains dependent on a future licensing deal.

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.

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.

PolyNovo delivered 16.1% revenue growth and a sharp improvement in operating cash flow in FY26, despite a lower statutory profit after a prior-year tax benefit and a fire-related write-off. The ASX-listed wound-care company now expects to lodge its U.S. PMA application for NovoSorb BTM before the end of 2026.

Telix’s Pixclara has become the first FDA-approved FET-PET imaging drug for glioma, opening a new US diagnostic pathway for adults and children. The approval is commercially significant, but pricing, reimbursement and launch timing remain undisclosed.

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.

A multimillion-dollar, multiyear NIH grant will fund an expanded access program for Neurizon’s investigational NUZ-001, potentially giving up to 200 US patients access to the therapy for as long as 96 weeks. The program is designed to add long-term safety, survival and biomarker data alongside the pivotal HEALEY ALS trial.

OncoSil Medical has secured $5.6 million from its three largest institutional investors to fund commercial launches of its OncoSil device in the United States and Australia. The commitments follow FDA and TGA approvals and would lift pro-forma cash to $12.1 million once completed.

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.

Immuron Limited has inked an exclusive US distribution deal for PROIBS®, a European-certified medical device targeting abdominal discomfort, marking a key step in its digestive health portfolio growth.