Blog
RSS FeedPosted by Michael Wonder on 25 Aug 2022
Myriad Genetics receives expanded coverage in Japan for use of BRACAnalysis Diagnostic System as a companion diagnostic for Lynparza in early-stage breast cancer
25 August 2022 - Myriad Genetics today announced Japan’s MHLW has granted expanded coverage for the use of Myriad’s BRACAnalysis ...
Posted by Michael Wonder on 23 Aug 2022
Pillar Biosciences receives China National Medical Products Administration approval for oncoReveal Dx colon cancer assay
22 August 2022 - Highly accurate, tissue based, next generation sequencing test approved in China as a companion diagnostic for ...
Posted by Michael Wonder on 13 Aug 2022
FDA approves first NGS based companion diagnostic to aid in selecting non-small-cell lung cancer patients with HER2 (ERBB2) activating mutations (SNVs & exon 20 insertions) for treatment with Enhertu
12 August 2022 - This approval marks the Oncomine Dx Target Test’s eighth companion diagnostic therapy selection indication ...
Posted by Michael Wonder on 11 Aug 2022
Roche receives FDA approval for VENTANA MMR RxDx panel to identify dMMR solid tumour patients and pMMR endometrial cancer patients eligible for Keytruda
11 August 2022 - Based on cancer biomarkers, the first-of-its-kind VENTANA MMR RxDx Panel helps identify solid tumour patients, including endometrial ...
Posted by Michael Wonder on 08 Aug 2022
Bot Image receives FDA clearance for artificial intelligence software used in detection and diagnosis of prostate cancer
8 August 2022 - Bot Image has developed an AI driven medical device CAD software to significantly improve the accuracy and ...
Posted by Michael Wonder on 04 Aug 2022
Economic evaluation of genomic/genetic tests: a review and future directions
1 August 2022 - It has been suggested that health economists need to improve their methods in order to meet the ...
Posted by Michael Wonder on 31 Jul 2022
FDA provides update on agency response to monkeypox outbreak
29 July 2022 - Today, the U.S. FDA is providing an update on its multi-pronged response to monkeypox in the United ...
Posted by Michael Wonder on 27 Jul 2022
FDA grants import discretion of Bracco's iodinated contrast medium Iomeron (iomeprol) to address supply shortages
27 July 2022 - Bracco Diagnostics today announced that the U.S. FDA granted import discretion of Iomeron (iomeprol) into the ...
Posted by Michael Wonder on 12 Jul 2022
Provepharm announces that it has received FDA approval for Bludigo (indigotindisulfonate sodium, USP) injection
12 July 2022 - Bludigo is the first and only indigotindisulfonate sodium injection, USP, drug product approved by the FDA. ...
Posted by Michael Wonder on 28 Jun 2022
Curium announces the submission of its marketing authorisation application for [18F]-DCFPyL to the EMA
27 June 2022 - Submission follows the completion of Phase III PYTHON clinical trial of [18F]-DCFPyL for recurrent prostate cancer in ...
Posted by Michael Wonder on 15 Jun 2022
NICE’s early value assessment for medtech: panning for nuggets of innovation gold
15 June 2022 - The explosion in digital health products has left NHS commissioners wondering how they can possibly sift out ...
Posted by Michael Wonder on 09 Jun 2022
U.S. FDA approves Foundation Medicine’s FoundationOne CDx as a companion diagnostic for Roche’s Rozlytrek (entrectinib)
9 June 2022 - This approval marks the first and only companion diagnostic indication for Rozlytrek, and another important milestone in ...
Posted by Michael Wonder on 30 May 2022
Illuccix reimbursement milestone and launch updates: pass-through status granted in the U.S.
30 May 2022 - Telix Pharmaceuticals today provides an update on the U.S. and Australian launch and reimbursement status for ...
Posted by Michael Wonder on 19 May 2022
Draft NICE guidance recommends innovative technology used to establish whether breast cancer has spread
17 May 2022 - A magnetic marker liquid injected into people with invasive breast cancer will help surgeons discover if the ...
Posted by Michael Wonder on 17 May 2022
FDA authorises first COVID-19 test available without a prescription that also detects influenza and RSV
16 May 2022 - The EUA authorises at home sample collection with testing performed in a laboratory. ...