17 March 2021 - BioFire Respiratory Panel 2.1 is the first COVID-19 diagnostic test granted marketing authorisation using the de novo ...
9 March 2021 - The Ventana ALK (D5F3) CDx Assay is now FDA approved as a companion diagnostic in four targeted ...
3 March 2021 - On Target Laboratories today announced that the U.S. FDA has accepted its new drug application for priority ...
25 February 2021 - Medexus Pharmaceuticals announced today that it has initiated the commercial launch of Gleolan in Canada, which had ...
24 February 2021 - Adjunct Professor John Skerritt has tasked the nation’s medical regulator with ensuring COVID-19 tests are successfully ...
23 December 2020 - The Directors are pleased to announce that Polarean has received notification of acceptance of the Company’s NDA ...
23 December 2020 - Bracco Diagnostics today announced that the U.S. FDA has approved ProHance (gadoteridol 279.3 mg/mL injection) for ...
16 March 2020 - The US FDA has approved the world’s first rapid at home COVID-19 test, developed by Brisbane-based ...
15 December 2020 - This genetic test identifies mutations in the PIK3CA gene that can cause cells to grow uncontrollably, which ...
14 December 2020 - Avelas Biosciences today announced that the company has received breakthrough therapy designation from the U.S. FDA ...
9 December 2020 - PDUFA action date of 28 May 2021 assigned by U.S. FDA. ...
7 December 2020 - Telix announces today that the Company’s preliminary application to the TGA for TLX591-CDx was made at ...
1 December 2020 - Today, the U.S. FDA approved Gallium 68 PSMA-11 (Ga 68 PSMA-11) – the first drug for ...
24 November 2020 - Telix Pharmaceuticals announces new drug application for TLX591-CDx. ...
17 November 2020 - Today, the U.S. FDA issued an emergency use authorisation for the first COVID-19 diagnostic test for self-testing ...