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 Sirturo (bedaquiline)
The CHMP has recommended conditional marketing for the novel treatment for Tuberculosis, Sirturo (bedaquiline 100mg tablets) from Janssen Cilag (Johnson...
Janssen Research & Development, LLC (Janssen) has announced that the Anti-Infective Drugs Advisory Committee of the U.S. Food and Drug...
The FDA has announced its approval of PaMZ (pretomanid), from TB Alliance, a new drug developed to treat Extensively Drug-Resistant Tuberculosis (XDR-TB)...
SIRTURO is indicated for use as part of an appropriate combination regimen for pulmonary multidrug-resistant tuberculosis (MDR-TB) in adult and paediatric patients (5 years to less than 18 years of age and weighing at least 15 kg) when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability (see sections 4.2, 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Janssen Pharmaceuticals has submitted a Marketing Authorisation Application to the EMA seeking conditional approval for the use of the investigational...
The FDA has granted accelerated approval to Sirturo (bedaquiline), from Janssen Therapeutics, for the treatment of pulmonary multi-drug resistant Tuberculosis...
The CHMP recommended granting a conditional marketing authorisation for Deltyba (delamanid) from Otsuka, for the treatment of adult patients with...