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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Updated NICE quality standard identifies areas for breast cancer improvement

15 June 2016 - NICE’s latest quality standard published today says people who have been diagnosed with a type of early ...

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FDA approves first blood test to detect gene mutation associated with non-small cell lung cancer

1 June 2016 - The U.S. FDA today approved the cobas EGFR Mutation Test v2, a blood-based companion diagnostic for the ...

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FDA approves new diagnostic imaging agent to detect rare neuroendocrine tumours

1 June 2016 - The U.S. FDA today approved Netspot, the first kit for the preparation of gallium Ga 68 dotatate ...

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FDA approves new diagnostic imaging agent to detect recurrent prostate cancer

27 May 2016 - The U.S. FDA today approved Axumin, a radioactive diagnostic agent for injection. Axumin is indicated for positron ...

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FDA approves Bayer's Gadavist (gadobutrol) injection as first contrast agent for use with magnetic resonance angiography of supra-aortic arteries

29 April 2016 - Bayer announced today that the U.S. FDA has approved Gadavist (gadobutrol) injection for use with magnetic resonance ...

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