FDA approves first PSMA-targeted PET imaging drug for men with prostate cancer

1 December 2020 - Today, the U.S. FDA approved Gallium 68 PSMA-11 (Ga 68 PSMA-11) – the first drug for ...

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Telix new drug application for prostate cancer imaging product accepted by US FDA

24 November 2020 - Telix Pharmaceuticals announces new drug application for TLX591-CDx. ...

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FDA authorises first COVID-19 test for self-testing at home

17 November 2020 - Today, the U.S. FDA issued an emergency use authorisation for the first COVID-19 diagnostic test for self-testing ...

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Health Canada approves Canada’s first HIV self test

3 November 2020 - For the first time, Canadians will have access to at-home HIV self test kits. bioLytical Laboratories ...

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MSAC publishes agenda for upcoming meeting

30 October 2020 - 16 agenda items for 26-27 November 2020 meeting. ...

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Astellas receives U.S. FDA fast track designation for ASP5354, an investigational near-infrared fluorescence imaging agent

28 October 2020 - Astellas Pharma announced today that the US FDA has granted fast track designation based on non-clinical and ...

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Roche to launch laboratory SARS-CoV-2 antigen test to support high-volume testing of suspected COVID-19 patients

13 October 2020 - The Elecsys SARS-CoV-2 Antigen test is an automated laboratory assay intended as an aid in the diagnosis ...

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Chembio Diagnostics receives FDA approval for DPP HIV-syphilis system

2 October 2020 - Chembio Diagnostics today announced that the U.S. FDA has approved the premarket approval application for the DPP ...

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Lantheus submits new drug application to the U.S. FDA for PyL (18F DCFPyL), a PSMA targeted prostate cancer imaging agent

30 September 2020 - Sep. 30, 2020-- Lantheus today announced the submission of a new drug application to the U.S. FDA ...

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FDA authorises first point of care antibody test for COVID-19

23 September 2020 - Today, the U.S. FDA issued an emergency use authorisation for the first serology (antibody) point of care ...

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Telix Pharmaceuticals submits new drug application to US FDA for prostate cancer imaging product

24 September 2020 - Telix Pharmaceuticals today announces it has submitted a new drug application to the United States FDA for ...

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Instrumentation Laboratory receives US FDA marketing authorisation for the first apixaban diagnostic test

22 September 2020 - The first direct oral anticoagulant test authorised for clinical use on automated hemostasis systems. ...

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Roche receives FDA approval for expanded use of the CINtec PLUS Cytology test to aid clinicians in preventing cervical cancer

16 September 2020 - Next generation biomarker cytology test supports World Health Organization’s goal to eliminate cervical cancer, which is nearly ...

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FDA publishes comparative performance data for COVID-19 molecular diagnostic tests

15 September 2020 - Today, the U.S. FDA published comparative performance data for some authorised COVID-19 molecular diagnostic tests.  ...

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Clarity Pharmaceuticals announces the US FDA grants rare paediatric disease designation to 64 Cu sartate, a diagnostic for the clinical management of neuroblastoma

9 September 2020 - Clarity Pharmaceuticals is pleased to announce that the U.S. FDA has granted rare paediatric disease designation to ...

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