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RSS FeedPosted by Michael Wonder on 06 Jul 2023
Moderna announces global regulatory submissions for its respiratory syncytial virus (RSV) vaccine, mRNA-1345
5 July 2023 - Moderna has submitted marketing authorization applications for the investigational RSV vaccine, mRNA-1345, with the European Medicines Agency, ...
Posted by Michael Wonder on 22 Jun 2021
Australia-Canada-Singapore-Switzerland-United Kingdom (Access) Consortium
22 June 2021 - The TGA is a member of the Access consortium along with Health Canada, Health Sciences Authority of ...
Posted by Michael Wonder on 05 Jul 2018
International work-sharing pilot - apalutamide (Erlyand)
5 July 2018 - Apalutamide (Erlyand) is the first medicine to be registered on the Australian Register of Therapeutic Goods ...
Posted by Michael Wonder on 17 Apr 2018
ACSS - NCE work-sharing pilot
17 April 2018 - The ACSS Consortium is a collaborative initiative of like-minded, medium-sized regulatory authorities between Australia's Therapeutic Goods Administration, ...