Janssen submits Phase 3 study data to EMA and FDA for SIRTURO® (bedaquiline)

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STREAM Stage 2 study data submitted as part of Type II Variation to European Medicines Agency (EMA) and supplemental New Drug Application to US Food and Drug Administration (FDA) aim to support the full and traditional approval of SIRTURO® (bedaquiline) in the European Union and US, respectively.

Read the full press release here.

 

For more TB news, check out the latest edition of the TB Online Weekly Newsletter (#35, 14 November 2023) with the latest TB advocacy and research updates.

 

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