Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 29 Aug 2024
Life Molecular Imaging receives FDA fast track designation for [18F]PI-2620 in Tau PET imaging across three neurodegenerative conditions
28 August 2024 - Life Molecular Imaging is pleased to announce that the US FDA granted fast track designation to [18F]PI-2620 ...
Posted by Michael Wonder on 28 Aug 2024
Telix submits NDA for TLX101-CDx (Pixclara) brain cancer imaging agent
28 August 2024 - Telix today announces it has submitted a new drug application to the US FDA for TLX101-CDx, (Pixclara, ...
Posted by Michael Wonder on 22 Aug 2024
Clarity receives FDA fast track designation for 64Cu-SAR-bisPSMA
22 August 2024 - Clarity Pharmaceuticals is pleased to announce that the US FDA has granted fast track designation for 64Cu-SAR-bisPSMA ...
Posted by Michael Wonder on 06 Aug 2024
Attralus receives breakthrough therapy designation for its pan-amyloid diagnostic PET imaging candidate 124I-evuzamitide (AT-01) for cardiac amyloidosis
5 August 2024 - A Phase 3 study for 124I-evuzamitide in patients with suspected cardiac amyloidosis is anticipated to begin ...