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RSS FeedPosted by Michael Wonder on 06 Oct 2021
Complete response letter received from FDA
6 October 2021 - Requirement to address approvability issues identified by FDA ahead of NDA resubmission ...
Posted by Michael Wonder on 05 Aug 2021
Pillar Biosciences receives premarket approval from FDA for its oncoReveal Dx lung and colon cancer assay
5 August 2021 - Pillar Biosciences today announced the U.S. FDA has given premarket approval to its oncoReveal Dx Lung ...
Posted by Michael Wonder on 19 Jul 2021
Foundation Medicine expands indication for FoundationOne Liquid CDx to be used as a companion diagnostic for Tabrecta (capmatinib)
15 July 2021 - Tabrecta is the first FDA approved MET inhibitor for patients with metastatic non-small cell lung cancer with ...
Posted by Michael Wonder on 04 Jul 2021
Sonic Healthcare USA to offer assay to aid in the selection of Jemperli (dostarlimab-gxly) therapy in endometrial cancer
2 July 2021 - LMC Pathology Services, a Sonic Healthcare USA Anatomic Pathology Practice, is the first reference laboratory in ...
Posted by Michael Wonder on 01 Jul 2021
FoundationOne CDx receives FDA approval as a companion diagnostic for Alunbrig (brigatinib) to identify patients with ALK positive metastatic non-small cell lung cancer
1 July 2021 - Foundation Medicine today announced that it has received approval from the U.S. FDA for FoundationOne CDx to ...
Posted by Michael Wonder on 27 May 2021
Lantheus receives U.S. FDA approval of Pylarify (piflufolastat F 18) injection, the first and only commercially available PSMA PET imaging agent for prostate cancer
27 May 2021 - Pylarify will be available immediately to imaging centres in parts of the mid-Atlantic and southern regions and ...
Posted by Michael Wonder on 26 May 2021
Illuminare-1, a novel nerve visualisation investigational fluorophore, granted fast track designation by U.S. FDA
25 May 2021 - Illuminare Biotechnologies announced that its novel nerve imaging agent, Illuminare-1, has been granted fast track designation by ...
Posted by Michael Wonder on 12 May 2021
Alume Biosciences granted FDA fast track designation of ALM-488 for surgical nerve visualisation
12 May 2021 - Fast track designation highlights the urgent need for improved intra-operative nerve identification. ...
Posted by Michael Wonder on 06 May 2021
Viome receives FDA approval for its unique mRNA technology and AI platform to detect cancers
6 May 2021 - FDA breakthrough designation validates Viome's proprietary mRNA analysing technology and state of the art AI platform to ...
Posted by Michael Wonder on 23 Apr 2021
Roche receives FDA approval for first companion diagnostic to identify endometrial cancer patients eligible for immunotherapy
23 April 2021 - VENTANA MMR RxDx Panel is the first immunohistochemistry predictive test in endometrial cancer for treatment with the ...
Posted 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 ...