FDA Panel Says Threat of MDR-TB Warrants Fast-Track for New Drugs
A Food and Drug Administration advisory committee has decided that the threat posed by MDR-TB merits a fast-track approval process for potential new treatments. The clock is ticking, as drug-resistant...
View ArticleAn Easier Path to New TB Tools?
The search for new TB drugs and diagnostics is a long and windy road, paved with regulatory bumps and expensive R & D hurdles. But the path could get a little smoother under an amendment recently...
View Article100th Antiretroviral Drug approved by FDA for PEPFAR
Federal officials today celebrated the approval of the 100th antiretroviral drug authorized under an expedited regulatory framework created five years ago, as a way to fast-track the delivery of cheap...
View ArticlePublic and Private Sector Partners Help to Jump Start Development of New TB...
This post is by Global Center Director Christine Lubinski. The excitement in the room was palatable today as FDA Commissioner Margaret Hamburg joined representatives from the Global Alliance for TB...
View ArticleDrug maker seeks approval for use against multidrug-resistant tuberculosis
Makers of an investigational tuberculosis drug that has been urged for “compassionate use” approval in South Africa have applied to the European Medicines Agency to market the medicine as part of a...
View ArticleGuns — or medicine? A doctor’s call, survey responses, and more in a...
A doctor’s call for healthy foreign policy debate: John May, a South Florida corrections physician and founder of Health through Walls, a nonprofit that brings medical system support to prisons in...
View ArticleFDA panel finds new type of TB drug effective, raising hopes for treatment of...
Dr. Dalene von Delft had a choice between dying or going deaf, and that was a choice only if the arduous treatment she was undergoing for drug-resistant tuberculosis worked. The South African...
View ArticleFDA TB drug approval a milestone, with caveats
The U.S. Food and Drug Administration’s approval of the first new drug to treat tuberculosis in nearly half a century and the agency’s first use of its accelerated approval process to speed...
View ArticleStudy highlights “missed opportunities” to prevent HIV infections with PrEP
Categories: HIV/AIDSTags: CDC, FDA, PReP, STIsIn the three years following the U.S. Food and Drug Administration’s approval of a daily oral antiretroviral medicine to prevent HIV infection, records...
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