Posted by Michael Wonder on 08 Nov 2023
Janssen submits Phase 3 study data to the European Medicines Agency and US Food and Drug Administration for Sirturo (bedaquiline)
7 November 2023 - STREAM Stage 2 study data submitted as part of type II variation to the EMA and supplemental new drug application to US FDA.
Janssen announced today the submission of a type II variation application to the EMA for the Company’s medicine Sirturo (bedaquiline).
A supplemental new drug application to the US FDA was also submitted in August 2023.
