TGA approves Illuccix for prostate cancer imaging

2 November 2021 - Telix is delighted to announce that the TGA has approved Illuccix (kit for the preparation of ...

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Roche’s Ventana PD-L1 (SP263) assay receives FDA approval as a companion diagnostic to identify certain non-small-cell lung cancer patients eligible for Tecentriq (atezolizumab)

22 October 2021 - The Ventana PD-L1 (SP263) assay helps determine which non-small-cell lung cancer patients may benefit from treatment with ...

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FDA grants breakthrough device designation for Biological Dynamics’ early stage pancreatic cancer detection test

20 October 2021 - Designation provides expedited regulatory review of Exo-PDAC, a liquid biopsy assay, built on the company’s Verita ...

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COVID-19 rapid antigen self-tests approved in Australia

13 October 2021 - The TGA has approved COVID-19 self-tests (home use tests) for supply in Australia from 1 November ...

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Agilent receives FDA companion diagnostic approval for Ki-67 IHC MIB-1 pharmDx in high risk early breast cancer

13 October 2021 - Agilent Technologies today announced its Ki-67 IHC MIB-1 pharmDx (Dako Omnis) is now FDA approved as ...

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Complete response letter received from FDA

6 October 2021 - Requirement to address approvability issues identified by FDA ahead of NDA resubmission ...

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Jubilant Radiopharma announces Eckert & Ziegler's GalliaPharm approved for use with NETSpot in Canada

22 September 2021 - Jubilant Radiopharma is the exclusive distributor of GalliaPharm in Canada. ...

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Pillar Biosciences receives premarket approval from FDA for its oncoReveal Dx lung and colon cancer assay

5 August 2021 - Pillar Biosciences today announced the U.S. FDA has given premarket approval to its oncoReveal Dx Lung ...

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Foundation Medicine expands indication for FoundationOne Liquid CDx to be used as a companion diagnostic for Tabrecta (capmatinib)

15 July 2021 - Tabrecta is the first FDA approved MET inhibitor for patients with metastatic non-small cell lung cancer with ...

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Sonic Healthcare USA to offer assay to aid in the selection of Jemperli (dostarlimab-gxly) therapy in endometrial cancer

2 July 2021 - LMC Pathology Services, a Sonic Healthcare USA Anatomic Pathology Practice, is the first reference laboratory in ...

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FoundationOne CDx receives FDA approval as a companion diagnostic for Alunbrig (brigatinib) to identify patients with ALK positive metastatic non-small cell lung cancer

1 July 2021 - Foundation Medicine today announced that it has received approval from the U.S. FDA for FoundationOne CDx to ...

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New cancer gene test: are you eligible?

29 June 2021 - In a world first, young Australians will be offered a genetic test to discover whether they carry ...

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Lantheus receives U.S. FDA approval of Pylarify (piflufolastat F 18) injection, the first and only commercially available PSMA PET imaging agent for prostate cancer

27 May 2021 - Pylarify will be available immediately to imaging centres in parts of the mid-Atlantic and southern regions and ...

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Illuminare-1, a novel nerve visualisation investigational fluorophore, granted fast track designation by U.S. FDA

25 May 2021 - Illuminare Biotechnologies announced that its novel nerve imaging agent, Illuminare-1, has been granted fast track designation by ...

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Alume Biosciences granted FDA fast track designation of ALM-488 for surgical nerve visualisation

12 May 2021 - Fast track designation highlights the urgent need for improved intra-operative nerve identification. ...

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