News about 'fda'

12 Mar 2019
On March 8th, TB Alliance announced its novel compound, Pretomanid, is currently being reviewed by the FDA for use against Tuberculosis. TB Alliance's press release can be found below: NEW YORK, NY (March 8, 2019)—TB Alliance’s new drug application (NDA) for the novel tuberculosis (TB) drug...
9 Aug 2017
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...
5 Jan 2013
Press Release from FDA can be found at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm333695.htm . Press Release from Janssen is below. FDA Grants Accelerated Approval for SIRTURO™ (bedaquiline) as Part of Combination Therapy to Treat Adults with Pulmonary Multi-Drug Resistant...
28 Nov 2012
Yesterday, Nov. 28th, the FDA Ant-infective Drug Advisory Committee voted to recommend Janssen ‘s Bedaquiline for accelerated approval for the treatment of MDR tuberculosis. You can access materials from the meeting at http://www.fda.gov/AdvisoryCommittees/Calendar/ucm321011.htm . The sponsor and...
4 Jul 2012
Structure of Bedaquiline This week it was announced the Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson, filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for their drug Bedaquiline (a.k.a. TMC-207). For additional information on...
20 Mar 2012
The audience takes in the promise of the NC--002 trial. During the “Cure All: A briefing on the status of the most promising new TB drugs research” sponsored by the Critical Path to New TB Drug Regimens (CPTR) on Monday, March 19, Dr. Mel Spigelman, CEO & President, of TB Alliance announced the...
10 Jan 2011
Ahmad Z, Peloquin CA, Singh RP, Derendorf H, Tyagi S, Ginsberg A, Grosset JH, Nuermberger EL. PA-824 exhibits time-dependent activity in a murine model of tuberculosis. Antimicrob Agents Chemother. 2011 Jan;55(1):239-45. Epub 2010 Oct 11.PMID: 20937781 [PubMed – in process] Researchers testing the...
14 Dec 2010
The Wall Street Journal Health Blog reported that the FDA issued a draft guidance for the drug industry “designed to encourage companies to work in tandem to develop two or more new drugs to be used in combination to treat cancer and infectious diseases, among other illnesses.” This is exciting...
10 Oct 2010
This post originally appeared on Science Speaks . US Food and Drug Administration The U.S. Food and Drug Administration (FDA) announced $2.9 million to support six research projects related to the diagnosis, treatment and prevention of tuberculosis on Monday. This investment is a component of the...