News

US FDA: Development of New Tuberculosis Drug Regimens-Scientific and Clinical Design Considerations

The United States Food and Drug Administration held a public workshop regarding scientific and clinical trial design considerations for development of new tuberculosis drug regimens. This public workshop was intended to provide information for and gain perspective pertaining to development efforts around new in vitro and in vivo models, new biomarkers and tuberculosis diagnostics, assessing the contribution of 2 or more new components used in combination for to a tuberculosis regimen and clinical trial design challenges.

The TB Workshop transcript is available here and the details of the workshop are on the FDA's website

More News
17 Sep 2019
Earlier this month, the NIH announced two new Funding Opportunity Annoucnements (FOAs) on the topic of Myeloid-Derived Suppressor Cells (MDSC) as potential therapeutic targets in TB/HIV co-infected patients. The purpose of these FOAs is to invite applications for support of innovative clinical,...
14 Aug 2019
FDA released the following press release on Wednesday, August 14th: The U.S. Food and Drug Administration today approved Pretomanid Tablets in combination with bedaquiline and linezolid for the treatment of a specific type of highly treatment-resistant tuberculosis (TB) of the lungs. “The threat of...
27 Jun 2019
-- Globe Newswire reported on June 20th -- Spero Therapeutics, Inc. , a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing treatments in high unmet need areas involving multi-drug resistant (MDR) bacterial infections and rare diseases, today...