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RSS FeedPosted by Michael Wonder on 14 Feb 2022
US FDA grants the coveted breakthrough designation for early stage prostate cancer detection blood test developed in India by Datar Cancer Genetics
14 February 2022 - It is the first blood test able to detect early stage prostate cancer with high accuracy ...
Posted by Michael Wonder on 18 Jan 2022
TGA ‘knowingly putting pharmacists in serious danger’
18 January 2022 - The pharmacists’ union has accused the medical regulator of putting workers and customers at risk of ...
Posted by Michael Wonder on 19 Dec 2021
FDA approves Telix’s prostate cancer imaging product, Illuccix
19 December 2021 - Telix Pharmaceuticals today announces that the United States FDA has approved Telix’s lead prostate cancer imaging product, ...
Posted by Michael Wonder on 12 Dec 2021
FDA approves NGS based companion diagnostic for EGFR exon20 insertion mutant non-small-cell lung cancer tumour tissue
9 December 2021 - Oncomine Dx Target Test now approved for 12 NSCLC targeted therapies globally. ...
Posted by Michael Wonder on 08 Dec 2021
FoundationOne CDx receives FDA approval as a companion diagnostic for BRAF inhibitor therapeutics in melanoma
8 December 2021 - Foundation Medicine’s tissue-based test is the first and only comprehensive genomic profiling test to be approved as ...
Posted by Michael Wonder on 29 Nov 2021
FDA approves new imaging drug to help identify ovarian cancer lesions
29 November 2021 - The U.S. Food and Drug Administration today approved Cytalux (pafolacianine), an imaging drug intended to assist ...
Posted by Michael Wonder on 04 Nov 2021
TGA approves Illuccix for prostate cancer imaging
2 November 2021 - Telix is delighted to announce that the TGA has approved Illuccix (kit for the preparation of ...
Posted by Michael Wonder on 25 Oct 2021
Roche’s Ventana PD-L1 (SP263) assay receives FDA approval as a companion diagnostic to identify certain non-small-cell lung cancer patients eligible for Tecentriq (atezolizumab)
22 October 2021 - The Ventana PD-L1 (SP263) assay helps determine which non-small-cell lung cancer patients may benefit from treatment with ...
Posted by Michael Wonder on 21 Oct 2021
FDA grants breakthrough device designation for Biological Dynamics’ early stage pancreatic cancer detection test
20 October 2021 - Designation provides expedited regulatory review of Exo-PDAC, a liquid biopsy assay, built on the company’s Verita ...
Posted by Michael Wonder on 14 Oct 2021
COVID-19 rapid antigen self-tests approved in Australia
13 October 2021 - The TGA has approved COVID-19 self-tests (home use tests) for supply in Australia from 1 November ...
Posted by Michael Wonder on 14 Oct 2021
Agilent receives FDA companion diagnostic approval for Ki-67 IHC MIB-1 pharmDx in high risk early breast cancer
13 October 2021 - Agilent Technologies today announced its Ki-67 IHC MIB-1 pharmDx (Dako Omnis) is now FDA approved as ...
Posted 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 22 Sep 2021
Jubilant Radiopharma announces Eckert & Ziegler's GalliaPharm approved for use with NETSpot in Canada
22 September 2021 - Jubilant Radiopharma is the exclusive distributor of GalliaPharm in Canada. ...
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 ...