Latest Fda News

Imricor Medical Systems updates its SEC Form 10 with minor SEC-driven revisions as it pushes forward with FDA clearances and clinical trials, reporting a $25.3 million net loss in 2025 amid early-stage commercialisation.

The FDA has removed the postmarketing cardiac repolarization study requirement for Clinuvel's SCENESSE®, reflecting confidence in its long-term safety profile. This marks a regulatory milestone for the only approved treatment for erythropoietic protoporphyria in the US.

Neuren Pharmaceuticals reported a solid A$30.4 million net profit in 2025, powered by a 15% rise in DAYBUE® royalties. The company is progressing its NNZ-2591 Phase 3 trial for Phelan-McDermid syndrome and has initiated a share buy-back amid perceived undervaluation.

EBR Systems secures Priority Review from Australia's TGA for its wireless cardiac pacing system, fast-tracking regulatory approval and expanding access for heart failure patients. This follows strong US commercial momentum after FDA approval.

Cambium Bio has secured FDA confirmation that a single pivotal Phase 3 trial plus confirmatory evidence will suffice for Biologics License Application submission for Elate Ocular, significantly reducing development expenses and accelerating the pathway to market.

Alterity Therapeutics has unveiled fresh Phase 2 data revealing ATH434’s ability to slow functional decline in Multiple System Atrophy patients, measured by the novel MuSyCA scale. This reinforces the drug’s disease-modifying potential ahead of pivotal Phase 3 trials.

Singular Health has received a US$500,000 payment from Provider Network Solutions following the deployment of an additional 500 3DICOM MD® licenses, marking progress in commercial adoption and cost-saving benefits within a major US healthcare network.

Recce Pharmaceuticals has cleared a critical regulatory hurdle in Indonesia with a successful inspection of its Phase 3 clinical trial site for diabetic foot infections, paving the way for potential approval in 2026 amid a large and growing market.

Starpharma has secured FDA alignment on the clinical development plan for its DEP® HER2 radiotherapy candidate, paving the way for a first-in-human phase 1 study in advanced HER2-positive cancers scheduled for H2 2026.

AdAlta, Oribiotech, and Cell Therapies have inked a Memorandum of Understanding to deploy Oribiotech’s IRO automated cell therapy manufacturing platform in Australia and Asia Pacific, aiming to slash costs and boost production speed for CAR-T therapies.

dorsaVi has confirmed that its proprietary RRAM memory technology and neuromorphic IP portfolio work seamlessly together, projecting a tenfold boost in performance for robotics and exoskeleton applications. This breakthrough lays the groundwork for smarter, faster, and more energy-efficient wearable and robotic devices operating at the ultra-edge.

Lumos Diagnostics has secured a key FDA 510(k) clearance with CLIA waiver for its FebriDx rapid test, unlocking a US$1 billion-plus market opportunity and triggering milestone payments exceeding US$6 million. The company reported a 37% revenue jump in Q3 FY26, supported by a A$20 million placement and ongoing clinical and development projects.