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RSS FeedPosted by Michael Wonder on 18 Nov 2020
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 ...
Posted by Michael Wonder on 04 Nov 2020
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 ...
Posted by Michael Wonder on 28 Oct 2020
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 ...
Posted by Michael Wonder on 13 Oct 2020
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 ...
Posted by Michael Wonder on 05 Oct 2020
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 ...
Posted by Michael Wonder on 02 Oct 2020
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 ...
Posted by Michael Wonder on 24 Sep 2020
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 ...
Posted by Michael Wonder on 24 Sep 2020
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 ...
Posted by Michael Wonder on 23 Sep 2020
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. ...
Posted by Michael Wonder on 17 Sep 2020
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 ...
Posted by Michael Wonder on 15 Sep 2020
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. ...
Posted by Michael Wonder on 09 Sep 2020
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 ...
Posted by Michael Wonder on 08 Sep 2020
Roche receives FDA clearance for BK virus quantitative test on cobas 6800/8800 Systems to support better care for transplant patients
8 September 2020 - New breakthrough device test expands Roche molecular test menu for transplant patients, enabling simultaneous testing of BK ...
Posted by Michael Wonder on 08 Sep 2020
RadioMedix and Curium announce FDA approval of Detectnet (copper Cu 64 dotatate injection) in the U.S.
7 September 2020 - RadioMedix and its commercial partner Curium announced today that Detectnet (copper Cu 64 dotatate injection) was approved ...
Posted by Michael Wonder on 01 Sep 2020
Roche receives FDA approval for first HIV-1/HIV-2 Qualitative Test on the cobas 6800/8800 Systems in the fight against HIV/AIDS
1 September 2020 - Detects, confirms and differentiates HIV-1 and HIV-2 infections providing clinicians with critical diagnostic data for personalised management ...