Blog
RSS FeedPosted by Michael Wonder on 03 Jul 2024
Gadopiclenol as an MRI contrast agent: first benefit assessment of a diagnostic agent
1 July 2024 - For the first time, IQWiG has evaluated a drug that is a diagnostic agent within the ...
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 23 Feb 2024
Curium announces submission of the marketing authorisation application for Pylclari, an innovative (18F)-PSMA PET tracer indicated in adults with prostate cancer to Swissmedic
22 February 2024 - Curium announced today that the marketing authorisation application for Pylclari (piflufolastat (18F)) submitted by exclusive Swiss ...
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 12 Dec 2023
The European Commission granted marketing authorisation for Vueway (gadopiclenol) in the European Union
11 December 2023 - Vueway is a new, highly stable, macrocyclic gadolinium-based contrast agent (GBCA) for contrast-enhanced magnetic resonance imaging (CE-MRI): ...
Posted by Michael Wonder on 13 Oct 2023
Vueway (gadopiclenol) receives positive CHMP opinion
12 October 2023 - The CHMP of the EMA recommended approval of the macrocyclic, high relaxivity Vueway (gadopiclenol) in adults ...
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. ...
Posted by Michael Wonder on 30 Sep 2023
FDA grants first marketing authorisation for a DNA test to assess predisposition for dozens of cancer types
29 September 2023 - Today, the US FDA grantedde novo marketing authorisation for the Invitae Common Hereditary Cancers Panel, ...
Posted by Michael Wonder on 04 Jul 2023
Biomarker tests for targeted oncology therapies pose tricky regulatory challenges
29 June 2023 - The US FDA recently announced the launch of a year-long pilot programme regarding diagnostic methods within oncology ...
Posted by Michael Wonder on 03 Jul 2023
Roche receives FDA clearance for additional Alzheimer's disease cerebrospinal fluid assays, supporting timely diagnosis and treatment decision-making
27 June 2023 - The Elecsys tTau/Abeta42 ratio helps clinicians define Alzheimer's disease biologically and expands Roche's Alzheimer's CSF portfolio to ...
Posted by Michael Wonder on 28 Jun 2023
FDA approves Bayer’s Ultravist (iopromide) injection for contrast-enhanced mammography
23 June 2023 - Ultravist-300, -370 is now the only contrast agent in the US indicated to visualise known or suspected ...
Posted by Michael Wonder on 30 May 2023
US FDA approves Blue Earth Diagnostics’ Posluma (flotufolastat F 18) injection, first radiohybrid PSMA targeted PET imaging agent for prostate cancer
30 May 2023 - Posluma will be commercially available in the United States in early June 2023. ...