01 August 2023
01 August 2023
The FDA also approved the first generic non-prescription naloxone drug in July 2023.
The approval was based on an interim analysis of data from Part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO Phase III trial.
The approval was based on data from the Phase III Marigold double-blind placebo-controlled trial.
InstaDeep is a UK-based technology provider in the fields of artificial intelligence and machine learning.
Mithra Pharmaceuticals is in line to receive €17.05m ($18.8m) in licencing fees, and milestone-based payments.
The Chiesi Farmaceutici had a global license, except in North America and France, for Raxone since 2019.
The additional aim of the first-in-human study is to determine the Phase II recommended dose.
The BLA is based on the results from the Phase III GLOW and SPOTLIGHT clinical trials.
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