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RSS FeedPosted by Michael Wonder on 10 May 2024
SN Bioscience receives FDA fast track designation for small cell lung cancer
9 May 2024 - SN Bioscience announced on 7 May that the FDA has granted fast track designation for small cell ...
Posted by Michael Wonder on 05 Dec 2023
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 ...
Posted by Michael Wonder on 13 Jul 2023
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. ...
Posted by Michael Wonder on 20 Feb 2023
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. ...
Posted by Michael Wonder on 27 Oct 2021
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 ...
Posted by Michael Wonder on 09 Oct 2020
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 ...
Posted by Michael Wonder on 28 Apr 2020
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 ...
Posted by Michael Wonder on 10 Mar 2020
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. ...