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 ...

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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 ...

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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.  ...

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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 ...

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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. ...

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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. ...

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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 ...

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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 ...

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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 ...

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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. ...

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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 ...

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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 ...

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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 ...

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TGA approves new diagnostic agent

31 August 2016 - The TGA has approved Juno Pharmaceuticals' Hexvix. ...

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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 ...

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