Latest Fda Approvals News

Vitasora Health has received $2.43 million from a cornerstone investor, advancing its $11 million capital raise and reinforcing its path to profitability by Q4 FY2026. The company’s expanding US partnerships and technology investments signal growing market confidence.

Imricor Medical Systems made significant regulatory strides with FDA submissions for its MRI-guided cardiac ablation devices and launched NorthStar commercially in Europe, even as it reported increased cash outflows in Q3 CY25.

BlinkLab Limited has completed its U.S. pilot study for the Dx 1 smartphone-based autism diagnostic device, demonstrating strong accuracy and securing FDA alignment for its pivotal trial. The results mark a significant step toward transforming early neurodevelopmental diagnostics.

Imagion Biosystems has made significant strides toward filing an IND application for its MagSense® HER2 breast cancer imaging agent, supported by positive FDA feedback and a recent $3.5 million capital raise to fund upcoming clinical trials.

Mesoblast Limited reports a 69% jump in net revenues from its pioneering cell therapy Ryoncil in Q1 FY2026, propelled by expanded physician adoption and new reimbursement pathways. The company also secures convertible note funding and plans pivotal adult trials.

Neuren Pharmaceuticals has secured FDA Fast Track designation for its drug NNZ-2591 targeting Phelan-McDermid syndrome, accelerating its path through clinical development. This milestone underscores the urgent need for treatments in rare neurodevelopmental disorders.

Race Oncology showcased compelling preclinical data at ESMO 2025 revealing that their drug RC220, combined with doxorubicin, not only shields the heart from toxicity but also boosts anticancer effects, supporting ongoing clinical trials.

Orthocell has boosted its investment in Marine Biomedical to secure exclusive global distribution rights for PearlBone™, an innovative bone substitute nearing FDA approval, enhancing its regenerative medicine portfolio.

Botanix Pharmaceuticals reports a strong start to FY26 with a 50% surge in Sofdra prescriptions and a 65% rise in net revenue, underpinned by a larger sales team and operational efficiencies.

Anteris Technologies has secured its first European regulatory clearance to commence the global PARADIGM Trial for its DurAVR Transcatheter Heart Valve, marking a significant step toward worldwide commercialization.

Biotron Limited is set to acquire Sedarex Limited, gaining global patents for SedRx, a next-generation general anaesthetic, supported by a $2.5 million capital raising to fund regulatory and development milestones.

Compumedics has secured a $2.15 million placement to fast-track commercialisation of its Somfit D device following early FDA approval, positioning the company for significant growth in the US home sleep testing market.