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RSS FeedPosted by Michael Wonder on 01 Jun 2020
Zionexa USA and PETNET Solutions announce FDA approval of Cerianna (Fluoroestradiol F 18)
27 May 2020 - Zionexa USA and PETNET Solutions have announced that the FDA has approved Cerianna (fluoroestradiol F 18) injection ...
Posted by Michael Wonder on 29 May 2020
FDA approves first drug to image tau pathology in patients being evaluated for Alzheimer’s disease
28 May 2020 - Today, the U.S. FDA approved Tauvid (flortaucipir F18) for intravenous injection, the first drug used to help ...
Posted by Michael Wonder on 08 Apr 2020
Advanced Accelerator Applications announces Health Canada approval of Netspot diagnostic imaging agent kit to detect neuroendocrine tumours
7 April 2020 - Netspot is the first and only kit for the preparation of gallium (68 Ga) oxodotreotide injection for ...
Posted by Michael Wonder on 12 Mar 2020
RadioMedix and Curium Announce copper Cu 64 dotatate injection was granted priority review by the U.S. FDA
11 March 2020 - RadioMedix and its commercial partner Curium announced the U.S. FDA has granted copper Cu 64 dotatate injection ...
Posted by Michael Wonder on 22 Feb 2020
FDA authorises marketing of the first genetic test to aid in the diagnosis of Fragile X syndrome
21 February 2020 - The U.S. Food and Drug Administration today authorised marketing of the first test to detect a genetic ...
Posted by Michael Wonder on 05 Feb 2020
FDA takes significant step in coronavirus response efforts, issues emergency use authorisation for the first 2019 novel coronavirus diagnostic
4 February 2020 - Critical milestone reached in response to this outbreak. ...
Posted by Michael Wonder on 28 Jan 2020
Jubilant Radiopharma Receives Approval from Health Canada for Drax Exametazime
27 January 2020 - Jubilant Radiopharma announced today that the company received approval from Health Canada for Drax Exametazine (Kit ...
Posted by Michael Wonder on 07 Jan 2020
RadioMedix and Curium announce FDA filing of copper Cu 64 dotatate injection new drug application
7 January 2020 - RadioMedix and its commercial partner Curium announced today that the new drug application for copper Cu 64 ...
Posted by Michael Wonder on 05 Dec 2019
FDA authorises marketing of diagnostic test that uses novel technology to detect MRSA bacteria
5 December 2019 - Today, the U.S. FDA authorised marketing of a new diagnostic test based on bacterial viability and novel ...
Posted by Michael Wonder on 06 Nov 2019
FDA authorises marketing of first next-generation sequencing test for detecting HIV-1 drug resistance mutations
5 November 2019 - Today, the U.S. FDA authorised marketing of a test to detect human immunodeficiency virus (HIV) Type-1 drug ...
Posted by Michael Wonder on 05 Nov 2019
GE Healthcare announces U.S. FDA approval of macrocyclic MRI contrast agent Clariscan (gadoterate meglumine) injection for intravenous use
4 November 2019 - Clariscan, approved in more than 55 countries globally with over four million patient doses shipped, is now ...
Posted by Michael Wonder on 25 Sep 2019
Proposal for value-based, tiered reimbursement for tumour biomarker tests to promote innovation and evidence generation
25 September 2019 - Cancer precision medicine depends on high-quality tumour biomarker tests for treatment selection. ...
Posted by Michael Wonder on 06 Aug 2019
Bracco Diagnostics receives U.S. FDA approval for Varibar Thin Liquid (barium sulphate) for oral suspension
5 August 2019 - Bracco Diagnostics today announced the FDA approval for Varibar Thin Liquid (barium sulphate) for oral suspension which ...
Posted by Michael Wonder on 15 Jul 2019
FDA approves Bayer's Gadavist (gadobutrol) injection as the first and only contrast agent for use in cardiac magnetic resonance imaging in adult patients with known or suspected coronary artery disease
15 July 2019 - Coronary artery disease is an important public health issue-- a disease that affects 16.5 million Americans. ...
Posted by Michael Wonder on 09 Jan 2019
OncoNano receives authorisation to proceed from FDA for IND application and fast track designation for ONM-100, intra-operative imaging agent to detect tumours and metastatic lymph nodes that often go undetected during surgery
4 January 2019 - FDA says proposed Phase 2 clinical trial may proceed. ...