TLX101-CDx (Pixclara) granted FDA fast track designation

16 April 2024 - Telix Pharmaceuticals today announces that the US FDA has granted fast track designation for the Company's investigational ...

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Curium announces submission of the marketing authorisation application for Pylclari, an innovative (18F)-PSMA PET tracer indicated in adults with prostate cancer to Swissmedic

22 February 2024 - Curium announced today that the marketing authorisation application for Pylclari (piflufolastat (18F)) submitted by exclusive Swiss ...

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Telix submits biologics license application for TLX250-CDx (Zircaix) for imaging of kidney cancer

19 December 2023 - Telix today announces that it has submitted its biologics license application to the United States US FDA ...

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The European Commission granted marketing authorisation for Vueway (gadopiclenol) in the European Union

11 December 2023 - Vueway is a new, highly stable, macrocyclic gadolinium-based contrast agent (GBCA) for contrast-enhanced magnetic resonance imaging (CE-MRI): ...

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Vueway (gadopiclenol) receives positive CHMP opinion

12 October 2023 - The CHMP of the EMA recommended approval of the macrocyclic, high relaxivity Vueway (gadopiclenol) in adults ...

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US FDA grants approval for Technegas

2 October 2023 - Strong pre-existing demand expected to drive sales momentum for an immediate US wide rollout. ...

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FDA grants first marketing authorisation for a DNA test to assess predisposition for dozens of cancer types

29 September 2023 - Today, the US FDA grantedde novo marketing authorisation for the Invitae Common Hereditary Cancers Panel, ...

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Biomarker tests for targeted oncology therapies pose tricky regulatory challenges

29 June 2023 - The US FDA recently announced the launch of a year-long pilot programme regarding diagnostic methods within oncology ...

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Roche receives FDA clearance for additional Alzheimer's disease cerebrospinal fluid assays, supporting timely diagnosis and treatment decision-making

27 June 2023 - The Elecsys tTau/Abeta42 ratio helps clinicians define Alzheimer's disease biologically and expands Roche's Alzheimer's CSF portfolio to ...

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FDA approves Bayer’s Ultravist (iopromide) injection for contrast-enhanced mammography

23 June 2023 - Ultravist-300, -370 is now the only contrast agent in the US indicated to visualise known or suspected ...

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US FDA approves Blue Earth Diagnostics’ Posluma (flotufolastat F 18) injection, first radiohybrid PSMA targeted PET imaging agent for prostate cancer

30 May 2023 - Posluma will be commercially available in the United States in early June 2023. ...

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Lumicell announces FDA acceptance and priority review of new drug application for Lumisight optical imaging agent for breast cancer

22 May 2023 - The system visually highlights cancer that may have otherwise been left behind and is designed to be ...

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FDA approves expanded indication for Telix's Illuccix to include patient selection for PSMA directed radioligand therapy

16 March 2023 - Telix Pharmaceuticals today announces that the US FDA has approved a supplementary new drug application for ...

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Roche receives FDA approval of label expansion for Ventana PD-L1 (SP263) assay to identify patients with locally advanced and metastatic non-small cell lung cancer eligible for Libtayo

6 March 2023 - The Ventana PD-L1 (SP263) assay helps determine which patients with non-small cell lung cancer may be eligible ...

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FoundationOne Liquid CDx receives FDA approval as a companion diagnostic for Rozlytrek (entrectinib)

4 January 2023 - Foundation Medicine’s liquid biopsy test can now be used by oncologists to identify more patients with rare ...

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