Medical imaging agent gozetotide approved for diagnosis of prostate cancer

12 February 2025 - Gozetotide binds to the cancer cells with prostate-specific membrane antigen on their surface, making them visible during ...

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Bracco Imaging receives FDA fast track designation for BR55, ultrasound molecular imaging agent for the detection of active bowel inflammation in Crohn's disease

6 February 2025 - BR55 is a contrast agent for ultrasound imaging targeted at a molecule expressed in angiogenesis, i.e., the ...

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Life Molecular Imaging secures FDA fast track designation for [18F] florbetaben in diagnosing cardiac AL and ATTR amyloidosis

21 January 2025 - [18F] florbetaben has been granted a fast track designation for cardiac amyloidosis, which will expedite the development ...

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US FDA approves FoundationOne CDx as a companion diagnostic for Ojemda (tovorafenib) to treat the most common form of childhood brain tumour in paediatric patients

17 January 2025 - The approval supports the identification of therapeutic options for patients with relapsed or refractory BRAF altered paediatric ...

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Illuccix receives European approval

17 January 2025 - Telix today announces that it has received a positive decision on the marketing authorisation application for ...

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Peter’s prostate cancer diagnosis came as a shock. Now, he wants to protect his kids.

14 January 2025 - Peter had no symptoms when he was diagnosed with prostate cancer. Now, he’d like to see an ...

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Vergent Bioscience receives FDA fast track designation for abenacianine for injection (VGT-309) to help surgeons visualise tumours in the lung during surgery

7 January 2025 - Abenacianine is an investigational tumour targeted fluorescent imaging agent that has demonstrated a promising safety profile and ...

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Telix files TLX250-CDx (Zircaix) BLA for kidney cancer imaging

30 December 2024 - Telix today announces that it has submitted its biologics license application to the US FDA for ...

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MHRA approves new diagnostic agent for adult patients showing signs of cognitive impairment for Alzheimer’s disease

27 November 2024 - The MHRA has approved the medicine flortaucipir (Tauvid), given to adults with memory problems so that doctors ...

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US FDA approves FoundationOne Liquid CDx as a companion diagnostic for Tepmetko (tepotinib) to identify patients with MET exon 14 skipping alterations in non-small cell lung cancer

18 November 2024 - FoundationOne Liquid CDx is the first FDA approved companion diagnostic to identify patients who may be ...

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FDA accepts new drug application and grants priority review for TLX101-CDx (Pixclara) brain cancer imaging agent

24 October 2024 - Telix Pharmaceuticals today announces that the US FDA has accepted the new drug application for TLX101-CDx (Pixclara), ...

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FDA approves NGS based companion diagnostic for first targeted therapy for patients with grade 2 IDH mutant glioma

21 October 2024 - Oncomine Dx target test to identify patients eligible for Servier’s Voranigo (vorasidenib) tablet, the only FDA ...

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Prostate cancer: significant additional benefit for PSMA diagnostics with gozetotide

15 October 2024 - Because of the direct link between diagnosis and therapy, the data from the early benefit assessment ...

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Health Canada approves label expansion for Telix’s Illuccix to include patient selection for PSMA targeted therapy

4 October 2024 - Telix Pharmaceuticals today announces that Health Canada has approved the use of Illuccix (kit for the ...

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FDA approves imaging drug for evaluation of myocardial ischaemia and infarction

27 September 2024 - The US FDA has approved Flyrcado (flurpiridaz F 18) in adult patients with known or suspected coronary ...

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