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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Viome receives FDA approval for its unique mRNA technology and AI platform to detect cancers

6 May 2021 - FDA breakthrough designation validates Viome's proprietary mRNA analysing technology and state of the art AI platform to ...

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Australia's TGA grants approval to first objective concussion diagnostic

4 May 2021 - Oculogica's EyeBOX is the only objective diagnostic cleared by the US FDA and Australia TGA as an ...

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Cancer deaths could be reduced with genomic testing investment, says National Oncology Alliance

26 April 2021 - Half of the more than 550,000 Australians expected to die from cancer in the next decade could ...

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Roche receives FDA approval for first companion diagnostic to identify endometrial cancer patients eligible for immunotherapy

23 April 2021 - VENTANA MMR RxDx Panel is the first immunohistochemistry predictive test in endometrial cancer for treatment with the ...

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Amgen launches Biomarker Assist, a program to help more patients with non-small cell lung cancer gain access to biomarker testing

19 April 2021 - Half of all patients with non-small cell lung cancer have oncogene mutations, yet many patients are not ...

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Biocartis announces US FDA 510(k) submission of its Idylla MSI test

20 April 2021 - First US FDA oncology assay submission for Biocartis. ...

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TGA accepts Telix’s prostate cancer imaging product submission and commences priority evaluation process

14 April 2021 - Telix is pleased to announce that the TGA has accepted the Company’s submission for the registration ...

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Terminal cancer patients denied new treatments due to slow TGA approval

31 March 2021 - Desperate cancer patients are begging Australia’s drugs regulator to save lives by speeding up approvals and cutting ...

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Amazon gets emergency FDA approval for at-home COVID-19 test kit

26 March 2021 - Amazon on Friday received emergency use authorisation from the FDA for an at-home COVID-19 testing kit that ...

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FDA authorises LetsGetChecked’s home collection coronavirus (COVID-19) test for direct to consumer purchase

24 March 2021 - The direct to consumer test is now authorised by the FDA to sell directly to consumers online ...

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DoorDash launches on-demand delivery of COVID-19 PCR test collection kits through partnerships with Vault Health and Everlywell

22 March 2021 - New partnerships make same-day delivery of FDA authorised COVID-19 test collection kits widely available to consumers across ...

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FDA permits marketing of first SARS-CoV-2 diagnostic test using traditional premarket review process

17 March 2021 - BioFire Respiratory Panel 2.1 is the first COVID-19 diagnostic test granted marketing authorisation using the de novo ...

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