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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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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OncoNano Medicine’s pegsitacianine granted breakthrough therapy designation for real-time surgical imaging by the FDA

4 January 2023 - OncoNano Medicine today announced that its lead clinical development candidate, pegsitacianine, a pH sensitive fluorescent nanoprobe ...

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FDA approves Polarean’s Xenoview (Xenon Xe 129 hyperpolarised) for use with MRI for the evaluation of lung ventilation

28 December 2022 - FDA approved indication includes both adolescents and adults representing a significant market opportunity ...

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On Target Laboratories announces expanded indication of Cytalux (pafolacianine) injection for detection of lung cancer during surgery

16 December 2022 - Cyralux is also the first and only targeted molecular imaging agent that illuminates ovarian cancer in ...

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PerkinElmer announces its EONIS SCID-SMA kit is first to receive marketing authorisation by US FDA for SMA screening in newborns

14 November 2022 - Building on its contributions to newborn screening globally, PerkinElmer’s latest FDA authorised assay enables the simultaneous ...

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