Latest Cancer Imaging News

Optiscan Imaging has submitted its FDA dossier for InSpecta®, marking a crucial step toward US veterinary market entry, while progressing clinical studies for InVue® and InForm® ahead of further FDA submissions in 2026.

TrivarX appoints Dr Danielle Meyrick as CEO to spearhead clinical trials and commercialisation of its novel stable isotope MRI brain cancer imaging platform, with Phase 1 studies on track for completion this year.

Clarity Pharmaceuticals has secured a major manufacturing deal with Nucleus RadioPharma to produce its next-generation prostate cancer imaging agent, 64Cu-SAR-bisPSMA, ramping up supply ahead of anticipated US market entry.

Clarity Pharmaceuticals has signed a significant manufacturing supply agreement with Theragenics to produce copper-64, a key isotope for its upcoming prostate cancer diagnostic, Cu-SAR-bisPSMA. This deal strengthens Clarity’s US supply network ahead of anticipated FDA approval and commercial launch.

Clarity Pharmaceuticals has unveiled compelling Phase II trial results showing its Cu-SAR-bisPSMA PET imaging agent significantly improves detection of prostate cancer recurrence over the current standard. The data, presented at the 2026 European Association of Urology Congress and accepted by European Urology journal, mark a key milestone ahead of regulatory submissions.

Telix Pharmaceuticals has resubmitted its New Drug Application to the FDA for TLX101-Px (Pixclara®), aiming to advance a novel PET imaging agent for glioma diagnosis. The resubmission addresses prior regulatory concerns with additional data, reinforcing hopes for expedited approval.

Clarity Pharmaceuticals has completed enrolment in its Phase III AMPLIFY trial for the Cu-SAR-bisPSMA imaging agent, advancing its bid for FDA approval in prostate cancer diagnostics.

Telix Pharmaceuticals delivered a strong 56% revenue increase in 2025, driven by U.S. sales of Illuccix and the launch of Gozellix, while advancing its therapeutic pipeline and expanding global manufacturing capabilities. Despite a net loss, the company is investing heavily in R&D and sustainability initiatives aligned with climate-related disclosures.

Telix Pharmaceuticals has lodged a European marketing authorization application for TLX101-Px, a novel PET imaging agent targeting glioma brain cancer, aiming to enhance diagnostic precision and patient access across major European markets.

Clarity Pharmaceuticals’ Cu-64 SAR-bisPSMA diagnostic agent significantly outperformed the current standard Ga-68 PSMA-11 in detecting prostate cancer recurrence, more than doubling lesion and patient detection rates in a pivotal head-to-head trial.

Imagion Biosystems has submitted its Investigational New Drug application to the U.S. FDA for its MagSense® HER2 Imaging Agent, marking a pivotal step toward launching a Phase 2 clinical trial for breast cancer detection.

Optiscan Imaging Ltd has made significant strides in clinical studies and regulatory readiness, partnering with Australian Clinical Labs and launching new cancer imaging trials as it prepares for multiple FDA submissions in 2026.