Bayer files for EU approval of gadoquatrane

10 July 2025 - Submission of marketing authorization application to the EMA seeking approval for investigational low dose gadoquatrane for contrast-enhanced ...

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FDA approves updated label for Lilly’s Amyvid (florbetapir F 18 injection) to support diagnosis of Alzheimer’s disease in patients

25 June 2025 -  Eli Lilly announced that the US FDA has approved a label update for Amyvid (florbetapir F ...

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Bayer files for approval of gadoquatrane in the US

17 June 2025 - Bayer today announced the submission of a new drug application to the US FDA for its ...

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Radiopharm Theranostics granted US FDA fast track designation for RAD101 imaging in brain metastases

11 June 2025 - Radiopharm Theranostics today announced that the US FDA has granted fast track designation for RAD101 to ...

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FDA clears first blood test used in diagnosing Alzheimer’s disease

16 May 2025 - New test provides less invasive option, reduces reliance on PET scans and increases diagnosis accessibility. ...

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Roche granted FDA breakthrough device designation for first AI-driven companion diagnostic for non-small cell lung cancer

29 April 2025 - The VENTANA TROP2 (EPR20043) RxDx device is an immunohistochemistry assay combined with a digital pathology algorithm to ...

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Telix provides regulatory update on TLX101-CDx

28 April 2028 - Telix Pharmaceuticals today announces that it has received a complete response letter from the US FDA ...

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World first as MHRA approves trofolastat for diagnostic imaging of prostate cancer in men

28 March 2025 - The MHRA has approved trofolastat (RoTecPSMA), the first prostate-specific membrane antigen (PSMA)-targeting product authorised for use with ...

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FDA approves new prostate cancer imaging agent Gozellix

21 March 2025 - Telix Pharmaceuticals today announces that the US FDA has approved its new drug application for Gozellix ...

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FDA accepts BLA for TLX250-CDx (Zircaix) for kidney cancer imaging, grants priority review

26 February 2025 - Telix today announces that the US FDA has accepted the biologics license application for its breakthrough investigational ...

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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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