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RSS FeedPosted 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 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 29 Mar 2022
Gadopiclenol marketing authorisation dossier submissions accepted for review by EMA and FDA
29 March 2022 - Priority review granted by U.S. FDA. ...
Posted by Michael Wonder on 16 Feb 2022
GE Healthcare's stress agent Rapiscan approved for use in stress cardiac magnetic resonance imaging
14 February 2022 - Already used in single photon emission computed tomography (SPECT) myocardial perfusion imaging for adult patients, Rapiscan is ...
Posted by Michael Wonder on 15 Dec 2020
Roche launches cobas PIK3CA mutation test for patients with advanced or metastatic breast cancer in countries accepting the CE mark
15 December 2020 - This genetic test identifies mutations in the PIK3CA gene that can cause cells to grow uncontrollably, which ...
Posted by Michael Wonder on 16 Dec 2016
Advanced Accelerator Applications announces European Commission approval of SomaKit TOC
15 December 2016 - AAA today announced that following a positive opinion issued by the EMA in October 2016, the European ...
Posted by Michael Wonder on 06 Aug 2016
ITM´s subsidiary ITG receives drug approval for EndolucinBeta
4 August 2016 - ITM Isotopen Technologien München AG today announced that the EMA has granted marketing authorization for EndolucinBeta of ...