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RSS FeedPosted 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 ...
Posted by Michael Wonder on 05 Aug 2024
FDA submission to expand minimum age for Xenoview
1 August 2024 - Polarean Imaging announces that it has submitted a new drug application supplement to the US FDA to ...
Posted by Michael Wonder on 01 Aug 2024
Guardant Health’s FDA approved Shield blood test now commercially available in US as a primary screening option for colorectal cancer
1 August 2024 - FDA approval announced earlier this week makes Shield first blood test that is approved for primary screening ...
Posted by Michael Wonder on 30 Jul 2024
FDA accepts Telix NDA for new prostate cancer imaging agent
23 July 2024 - Telix today announces that the US FDA has accepted the filing of its new drug application for ...
Posted by Michael Wonder on 05 Jun 2024
Telix completes TLX250-CDx (Zircaix) BLA submission for kidney cancer imaging
3 June 2024 - Telix today announces that it has completed the submission of a biologics license application to the ...
Posted by Michael Wonder on 28 May 2024
Telix submits NDA for new prostate cancer imaging agent
27 May 2024 - Telix Pharmaceuticals today announces it has submitted a new drug application to the US FDA for ...
Posted by Michael Wonder on 18 Apr 2024
Lumicell’s cutting-edge imaging platform receives historic FDA approval to illuminate residual breast cancer
18 April 2024 - Lumisight and Lumicell DVS previously received FDA fast track and breakthrough device designations, respectively. ...
Posted by Michael Wonder on 16 Apr 2024
TLX101-CDx (Pixclara) granted FDA fast track designation
16 April 2024 - Telix Pharmaceuticals today announces that the US FDA has granted fast track designation for the Company's investigational ...
Posted by Michael Wonder on 18 Dec 2023
Telix submits biologics license application for TLX250-CDx (Zircaix) for imaging of kidney cancer
19 December 2023 - Telix today announces that it has submitted its biologics license application to the United States US FDA ...
Posted by Michael Wonder on 03 Oct 2023
US FDA grants approval for Technegas
2 October 2023 - Strong pre-existing demand expected to drive sales momentum for an immediate US wide rollout. ...