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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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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Perspective Therapeutics granted fast track designation for VMT01 for the diagnosis and treatment of MC1R positive melanoma

5 September 2024 - Perspective Therapeutics today announced that the US FDA granted fast track designation for the development of ...

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FDA approves Illumina cancer biomarker test with two companion diagnostics to rapidly match patients to targeted therapies

27 August 2024 - TruSight Oncology Comprehensive is the first US FDA approved, distributable comprehensive genomic profiling Iin vitro diagnostic kit ...

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Life Molecular Imaging receives FDA fast track designation for [18F]PI-2620 in Tau PET imaging across three neurodegenerative conditions

28 August 2024 - Life Molecular Imaging is pleased to announce that the US FDA granted fast track designation to [18F]PI-2620 ...

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Telix submits NDA for TLX101-CDx (Pixclara) brain cancer imaging agent

28 August 2024 - Telix today announces it has submitted a new drug application to the US FDA for TLX101-CDx, (Pixclara, ...

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Clarity receives FDA fast track designation for 64Cu-SAR-bisPSMA

22 August 2024 - Clarity Pharmaceuticals is pleased to announce that the US FDA has granted fast track designation for 64Cu-SAR-bisPSMA ...

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Attralus receives breakthrough therapy designation for its pan-amyloid diagnostic PET imaging candidate 124I-evuzamitide (AT-01) for cardiac amyloidosis

5 August 2024 - A Phase 3 study for 124I-evuzamitide in patients with suspected cardiac amyloidosis is anticipated to begin ...

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FDA submission to expand minimum age for Xenoview

1 August 2024 - Polarean Imaging announces that it has submitted a new drug application supplement to the US FDA to ...

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Guardant Health’s FDA approved Shield blood test now commercially available in US as a primary screening option for colorectal cancer

1 August 2024 - FDA approval announced earlier this week makes Shield first blood test that is approved for primary screening ...

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FDA accepts Telix NDA for new prostate cancer imaging agent

23 July 2024 - Telix today announces that the US FDA has accepted the filing of its new drug application for ...

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

3 June 2024 - Telix today announces that it has completed the submission of a biologics license application to the ...

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Telix submits NDA for new prostate cancer imaging agent

27 May 2024 - Telix Pharmaceuticals today announces it has submitted a new drug application to the US FDA for ...

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