Latest Fda Approval News

Imugene Limited has launched a A$37.5 million capital raising to advance its promising off-the-shelf CAR T therapy, azer-cel, following encouraging Phase 1b data showing a 75% overall response rate in lymphoma patients.

Lumos Diagnostics has inked a landmark six-year exclusive distribution agreement with PHASE Scientific for its FebriDx® rapid diagnostic test in the US, potentially unlocking nearly half a billion Australian dollars in revenue contingent on FDA approval.

INOVIQ Limited reports strong clinical validation for its EXO-OC ovarian cancer screening test and promising preclinical results for CAR-exosome therapeutics targeting aggressive cancers.

Island Pharmaceuticals has accelerated its acquisition of the Galidesivir antiviral program from BioCryst Pharmaceuticals, adding a clinically advanced asset with significant US government backing and a promising regulatory pathway.

Vitasora Health has completed the first tranche of its $11 million capital raise, positioning the company to fund growth initiatives and reach cash flow breakeven in the second half of fiscal 2026.

BlinkLab has expanded its pivotal FDA autism diagnostic trial by adding the University of Nebraska Medical Center as a second U.S. clinical site, advancing toward broader validation and regulatory clearance.

Botanix Pharmaceuticals reports robust early sales and expanding prescriber engagement for Sofdra™, its FDA-approved topical gel for excessive underarm sweating, signaling promising growth ahead.

Cochlear Limited has secured FDA approval for its latest Nucleus Nexa System and Kanso 3 sound processors, setting the stage for a US market debut in early FY26.

Nanosonics has launched trophon3, its next-generation ultrasound disinfection device, alongside a software upgrade for existing users, promising faster cycles and enhanced digital integration.

Vitasora Health Limited has raised $11 million in a well-supported placement, positioning the company to achieve cash flow breakeven in the second half of FY2026. The capital injection underscores strong investor confidence following key contract expansions and operational milestones.

EMVision Medical Devices has activated five of six pivotal trial sites for its emu™ bedside brain scanner, advancing towards FDA clearance while launching a parallel innovation study in Australia.

Mesoblast has secured FDA agreement on key requirements for its Biologics License Application for Revascor, targeting ischemic heart failure patients with reduced ejection fraction. The company aims for accelerated approval by year-end 2025.