Latest Fda News

TruScreen has secured clinical validation from the world’s largest cervical screening study in China, setting the stage for rapid market expansion across Asia, Africa, and Europe.

EBR Systems has kicked off a fully underwritten 1-for-2 entitlement offer priced at $0.38 per CDI, aiming to raise $85.6 million to accelerate commercialisation and manufacturing of its wireless cardiac pacing technology.

Island Pharmaceuticals is accelerating development of its broad-spectrum antiviral Galidesivir, progressing clinical, regulatory, and manufacturing milestones under the FDA Animal Rule pathway with expanded USAMRIID collaboration and biodefence positioning.

Imricor Medical Systems has submitted the third of four Premarket Approval modules to the FDA, marking a key step towards US approval of its MR-guided cardiac ablation devices.

Argenica has completed the last FDA-mandated cardiac safety assay for its stroke drug ARG-007, paving the way to lift the clinical hold and initiate Phase 2b trials in the US.

Syntara Limited has completed a $0.84 million Share Purchase Plan, boosting its total capital raise to $8.84 million to fund multiple clinical trials and patent development through to Q3 2027.

ImpediMed has successfully closed an oversubscribed Share Purchase Plan, raising $2.1 million following a $13.2 million institutional placement. The strong shareholder response underscores confidence ahead of a key shareholder vote.

Island Pharmaceuticals has expanded its partnership with USAMRIID to conduct a pivotal Galidesivir dose optimisation study against Marburg virus, targeting topline results in the second half of 2026.

Imugene’s off-the-shelf CAR T therapy azer-cel has won FDA Fast Track Designation for relapsed or refractory CLL/SLL and MZL, backed by compelling Phase 1b response rates.

OncoSil Medical has cleared a major regulatory hurdle as its Humanitarian Device Exemption application nears FDA approval, while its TRIPP-FFX trial shows promising results combining OncoSil with standard chemotherapy for pancreatic cancer.

Resonance Health is progressing its MRI Liver Fibrosis device through late-stage clinical validation, targeting FDA biomarker qualification, while maintaining a profitable SaaMD platform and forecasting $16 million revenue for FY26.

Alterity Therapeutics has clinched FDA agreement on the pivotal Phase 3 trial design for ATH434, targeting Multiple System Atrophy, with the trial set to begin by the end of 2026.