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RSS FeedPosted by Michael Wonder on 30 Apr 2025
Roche granted FDA breakthrough device designation for first AI-driven companion diagnostic for non-small cell lung cancer
29 April 2025 - The VENTANA TROP2 (EPR20043) RxDx device is an immunohistochemistry assay combined with a digital pathology algorithm to ...
Posted by Michael Wonder on 28 Apr 2025
Telix provides regulatory update on TLX101-CDx
28 April 2028 - Telix Pharmaceuticals today announces that it has received a complete response letter from the US FDA ...
Posted by Michael Wonder on 23 Mar 2025
FDA approves new prostate cancer imaging agent Gozellix
21 March 2025 - Telix Pharmaceuticals today announces that the US FDA has approved its new drug application for Gozellix ...
Posted by Michael Wonder on 27 Feb 2025
FDA accepts BLA for TLX250-CDx (Zircaix) for kidney cancer imaging, grants priority review
26 February 2025 - Telix today announces that the US FDA has accepted the biologics license application for its breakthrough investigational ...
Posted by Michael Wonder on 06 Feb 2025
Bracco Imaging receives FDA fast track designation for BR55, ultrasound molecular imaging agent for the detection of active bowel inflammation in Crohn's disease
6 February 2025 - BR55 is a contrast agent for ultrasound imaging targeted at a molecule expressed in angiogenesis, i.e., the ...
Posted by Michael Wonder on 21 Jan 2025
Life Molecular Imaging secures FDA fast track designation for [18F] florbetaben in diagnosing cardiac AL and ATTR amyloidosis
21 January 2025 - [18F] florbetaben has been granted a fast track designation for cardiac amyloidosis, which will expedite the development ...
Posted by Michael Wonder on 19 Jan 2025
US FDA approves FoundationOne CDx as a companion diagnostic for Ojemda (tovorafenib) to treat the most common form of childhood brain tumour in paediatric patients
17 January 2025 - The approval supports the identification of therapeutic options for patients with relapsed or refractory BRAF altered paediatric ...
Posted by Michael Wonder on 08 Jan 2025
Vergent Bioscience receives FDA fast track designation for abenacianine for injection (VGT-309) to help surgeons visualise tumours in the lung during surgery
7 January 2025 - Abenacianine is an investigational tumour targeted fluorescent imaging agent that has demonstrated a promising safety profile and ...
Posted by Michael Wonder on 30 Dec 2024
Telix files TLX250-CDx (Zircaix) BLA for kidney cancer imaging
30 December 2024 - Telix today announces that it has submitted its biologics license application to the US FDA for ...
Posted by Michael Wonder on 28 Nov 2024
US FDA approves FoundationOne Liquid CDx as a companion diagnostic for Tepmetko (tepotinib) to identify patients with MET exon 14 skipping alterations in non-small cell lung cancer
18 November 2024 - FoundationOne Liquid CDx is the first FDA approved companion diagnostic to identify patients who may be ...
Posted by Michael Wonder on 23 Oct 2024
FDA accepts new drug application and grants priority review for TLX101-CDx (Pixclara) brain cancer imaging agent
24 October 2024 - Telix Pharmaceuticals today announces that the US FDA has accepted the new drug application for TLX101-CDx (Pixclara), ...
Posted by Michael Wonder on 23 Oct 2024
FDA approves NGS based companion diagnostic for first targeted therapy for patients with grade 2 IDH mutant glioma
21 October 2024 - Oncomine Dx target test to identify patients eligible for Servier’s Voranigo (vorasidenib) tablet, the only FDA ...
Posted by Michael Wonder on 30 Sep 2024
FDA approves imaging drug for evaluation of myocardial ischaemia and infarction
27 September 2024 - The US FDA has approved Flyrcado (flurpiridaz F 18) in adult patients with known or suspected coronary ...
Posted by Michael Wonder on 05 Sep 2024
Perspective Therapeutics granted fast track designation for VMT01 for the diagnosis and treatment of MC1R positive melanoma
5 September 2024 - Perspective Therapeutics today announced that the US FDA granted fast track designation for the development of ...
Posted by Michael Wonder on 29 Aug 2024
FDA approves Illumina cancer biomarker test with two companion diagnostics to rapidly match patients to targeted therapies
27 August 2024 - TruSight Oncology Comprehensive is the first US FDA approved, distributable comprehensive genomic profiling Iin vitro diagnostic kit ...