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RSS FeedPosted 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. ...
Posted by Michael Wonder on 09 Jan 2019
RadioMedix and Curium announce FDA fast track designation for 64Cu dotatate
9 January 2019 - RadioMedix and its commercial partner Curium announced today that their investigational diagnostic radiopharmaceutical, 64Cu dotatate, was granted ...
Posted by Michael Wonder on 10 Dec 2018
Blue Earth Diagnostics announces U.S. FDA filing acceptance of supplemental new drug application for 18F-fluciclovine PET Imaging in Glioma
10 December 2018 - The application seeks to expand Axumin (fluciclovine F 18) label for use in detection and continuing ...
Posted by Michael Wonder on 03 Oct 2018
Axumin (fluciclovine (18F)) receives positive recommendation from Transparency Committee of the French HAS for use in PET imaging of suspected recurrent prostate cancer
2 October 2018 - Blue Earth Diagnostics, a leading molecular imaging diagnostics company, today announced that the Transparency Committee of ...
Posted by Michael Wonder on 29 Jun 2017
In an overlooked corner of pharma, drastic price hikes hit medicines for radiology scans
29 June 2017 - Three years ago, pharmacist Dennis McClure was stunned by news from a key supplier. ...
Posted by Michael Wonder on 27 May 2017
Piramal Imaging and IsoLogic Innovative Radiopharmaceuticals announce commercial approval of Neuraceq by Health Canada
28 February 2017 - Piramal Imaging and IsoLogic Innovative Radiopharmaceuticals today announce that Health Canada has issued a Notice of ...
Posted by Michael Wonder on 31 Mar 2017
Proposal to list 5-aminolevulinic acid hydrochloride (Gliolan) in the Hospital medicines list
31 March 2017 - PHARMAC is seeking feedback on a proposal to list 5-aminolevulinic acid hydrochloride (Gliolan) through a provisional ...
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 31 Aug 2016
TGA approves new diagnostic agent
31 August 2016 - The TGA has approved Juno Pharmaceuticals' Hexvix. ...
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 ...