Blog
RSS FeedPosted by Michael Wonder on 11 Jan 2021
Myriad Genetics receives first reimbursement decision for myChoice diagnostic system in Japan, enabling women with ovarian cancer to benefit from treatment with Zejula
8 January 2021 - Myriad Genetics announced today that it received its first reimbursement decision for the Myriad myChoice Diagnostic System, ...
Posted by Michael Wonder on 27 Dec 2020
FDA acceptance for the filing of new drug application
23 December 2020 - The Directors are pleased to announce that Polarean has received notification of acceptance of the Company’s NDA ...
Posted by Michael Wonder on 23 Dec 2020
FDA approves Bracco Diagnostics' ProHance (gadoteridol) Injection, 279.3 mg/mL, for paediatric patients younger than two years
23 December 2020 - Bracco Diagnostics today announced that the U.S. FDA has approved ProHance (gadoteridol 279.3 mg/mL injection) for ...
Posted by Michael Wonder on 16 Dec 2020
US FDA approves world’s first rapid Covid test from Brisbane’s Ellume
16 March 2020 - The US FDA has approved the world’s first rapid at home COVID-19 test, developed by Brisbane-based ...
Posted by Michael Wonder on 15 Dec 2020
Roche launches cobas PIK3CA mutation test for patients with advanced or metastatic breast cancer in countries accepting the CE mark
15 December 2020 - This genetic test identifies mutations in the PIK3CA gene that can cause cells to grow uncontrollably, which ...
Posted by Michael Wonder on 14 Dec 2020
Avelas receives FDA breakthrough therapy designation for pegloprastide (AVB-620) for use during breast cancer surgery
14 December 2020 - Avelas Biosciences today announced that the company has received breakthrough therapy designation from the U.S. FDA ...
Posted by Michael Wonder on 10 Dec 2020
Lantheus Holdings announces acceptance and priority review of new drug application for PyLTM (18F DCFPyL), a PSMA targeted prostate cancer PET imaging agent
9 December 2020 - PDUFA action date of 28 May 2021 assigned by U.S. FDA. ...
Posted by Michael Wonder on 08 Dec 2020
Telix granted TGA priority review for prostate cancer imaging
7 December 2020 - Telix announces today that the Company’s preliminary application to the TGA for TLX591-CDx was made at ...
Posted by Michael Wonder on 01 Dec 2020
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 ...
Posted by Michael Wonder on 24 Nov 2020
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. ...
Posted 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 ...