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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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. ...

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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 ...

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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 ...

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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 ...

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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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