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Approval from FDA and European Commission for Sirturo (bedaquiline) as part of combination therapy in adult and pediatric patients with pulmonary tuberculosis due to mycobacterium tuberculosis – Johnson & Johnson

Written by | 6 Jul 2024

Johnson & Johnson announced that the FDA has issued traditional approval for Sirturo (bedaquiline) as part of combination therapy in adult and pediatric patients (5 years and older… read more.

Submission of phase III study data on pulmonary tuberculosis to the EMA and FDA for Sirturo (bedaquiline) – Janssen Pharma

Written by | 15 Nov 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), announced the submission of a Type II Variation application to the European Medicines Agency (EMA) for the Company’s medicine… read more.

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