Osteal Therapeutics’ VT-X7 receives FDA’s breakthrough therapy designation for the treatment of periprosthetic joint infection of the hip and knee

5 December 2023 - The US FDA granted breakthrough therapy designation for VT-X7, Osteal Therapeutics’ investigational drug therapy for periprosthetic joint ...

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Dr. Reddy’s proposed rituximab biosimilar application accepted for review by US FDA, EMA and MHRA

12 July 2023 - Following dossier submission in April 2023, the regulatory agencies have now accepted the dossier for review. ...

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Azafaros receives additional regulatory designations for AZ-3102 from FDA, EMA and MHRA

20 February 2023 - Azafaros today announced its progress in on-going interactions with health authorities regarding its lead asset, AZ-3102. ...

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FDA collaborates with Health Canada and UK’s MHRA to foster good machine learning practice

27 October 2021 - Today, the U.S. FDA, Health Canada and the United Kingdom’s MHRA jointly issued the “Good Machine Learning ...

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MHRA to join Project Orbis

8 October 2020 - The UK is set to join the US FDA's Project Orbis at the start of next ...

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In race for a coronavirus vaccine, an Oxford group leaps ahead

27 April 2020 - As scientists at the Jenner Institute prepare for mass clinical trials, new tests show their vaccine to ...

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Inappropriate use of progression-free survival in cancer drug approvals

10 March 2020 - New drugs should be judged on overall survival or quality of life, preferably both. ...

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