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May 24, 2022
A new initiative aims to speed the approval of and access to new drugs for young patients around the world, while limiting the number of children needed for testing in clinical trials.
AstraZeneca's recombinant COVID-19 vaccine, originally invented by the University of Oxford, has been approved as a third dose booster vaccine in the EU.
EMA has recommended the marketing authorization of Xenpozyme (olipudase alfa) in the European Union.
Investment has been made into a new science hub at the University of Edinburgh for the development of treatments for lung infections and future pandemics.
May 23, 2022
AstraZeneca has signed a license agreement with RQ Biotechnology for monoclonal antibodies to treat COVID-19.
PTC Therapeutics has received a positive opinion from EMA for Upstaza for the treatment of AADC deficiency.
The final guidance addresses safety aspects of container and carton labeling design.
May 20, 2022
The agency is asking drug manufacturers to ensure a strong supply chain by developing risk management plans.
Catalent has announced a $175 million project to expand its manufacturing facility for large scale oral dose forms at its Winchester, Ky, site.
FDA has approved Mounjaro (tirzepatide) injections as a treatment to improve blood sugar control in adults with type 2 diabetes.