Janssen Therapeutics has obtained accelerated approval from FDA for Sirturo (bedaquiline) tablets as part of combination therapy to treat adult patients with pulmonary multi-drug resistant tuberculosis (MDR-TB). The surrogate endpoint of ...
Tags: Janssen Therapeutics, accelerated approval, FDA, Sirturo tablets
Janssen-Cilag International has submitted a Marketing Authorisation Application to the European Medicines Agency (EMA) seeking conditional approval to use the investigational drug bedaquiline (TMC207) as an oral treatment, to be used as ...
Tags: investigational drug bedaquiline, multi-drug resistant tuberculosis
Janssen Research & Development company has submitted bedaquiline (TMC207) new drug application (NDA) to the US Food and Drug Administration (FDA) for approval. Bedaquiline,an investigational drug administered orally,is used as part of ...
Tags: FDA, new drug application, investigational drug, pulmonary