Latest Headlines

Latest Headlines

J&J wins accelerated OK for first new TB drug in 40 years

On the last day of the year the FDA came through with a rapid-fire approval of Johnson & Johnson's bedaquiline, the first new treatment for drug-resistant tuberculosis in four decades.

J&J preps case for quick FDA approval of new TB drug

Later in the week a panel of outside FDA experts will give J&J's bedaquiline team a thorough examination to see whether the company warrants a preliminary approval based on Phase II data. And today the agency released its carefully neutral view of the data on safety and efficacy.

J&J rushes drug-resistant TB therapy bedaquiline to FDA

Armed with only a set of mid-stage data on its experimental therapy for drug-resistant TB, J&J's Janssen has tossed its NDA to the FDA in search of an accelerated approval.