Blog
RSS FeedPosted by Michael Wonder on 20 Apr 2021
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 ...
Posted by Michael Wonder on 20 Apr 2021
Biocartis announces US FDA 510(k) submission of its Idylla MSI test
20 April 2021 - First US FDA oncology assay submission for Biocartis. ...
Posted by Michael Wonder on 29 Mar 2021
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 ...
Posted by Michael Wonder on 24 Mar 2021
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 ...
Posted by Michael Wonder on 24 Mar 2021
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 ...
Posted by Michael Wonder on 17 Mar 2021
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 ...
Posted by Michael Wonder on 09 Mar 2021
Roche receives FDA approval for Ventana ALK (D5F3) CDx assay to identify lung cancer patients eligible for targeted treatment with Lorbrena (lorlatinib)
9 March 2021 - The Ventana ALK (D5F3) CDx Assay is now FDA approved as a companion diagnostic in four targeted ...
Posted by Michael Wonder on 03 Mar 2021
On Target Laboratories announces U.S. FDA acceptance and priority review of new drug application for pafolacianine sodium injection for identification of ovarian cancer during surgery
3 March 2021 - On Target Laboratories today announced that the U.S. FDA has accepted its new drug application for priority ...
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 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 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. ...