Bedaquiline: First FDA-approved tuberculosis drug in 40 years
نویسندگان
چکیده
منابع مشابه
FDA approval of bedaquiline--the benefit-risk balance for drug-resistant tuberculosis.
n engl j med 371;8 nejm.org august 21, 2014 689 regimen is not otherwise available.1 One complexity facing the FDA in reviewing the bedaquiline marketing application was that in one of the phase 2 studies, there were more deaths among patients who had bedaquiline added to a background antimycobacterial drug regimen than among those who had placebo added to the same regimen, despite relatively c...
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Sipuleucel-T (PROVENGE; Dendreon) is the first therapeutic cancer vaccine to be approved by the U.S. Food and Drug Administration. In men who have metastatic castration-resistant prostate cancer with no or minimal symptoms, sipuleucel-T prolongs median survival by 4.1 months compared with results in those treated with placebo. At 3 years, the proportion of patients in the vaccine group who were...
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Spinal muscular atrophy (SMA) is one of the leading genetic diseases of children and infants. SMA is caused by deletions or mutations of Survival Motor Neuron 1 (SMN1) gene. SMN2, a nearly identical copy of SMN1, cannot compensate for the loss of SMN1 due to predominant skipping of exon 7. While various regulatory elements that modulate SMN2 exon 7 splicing have been proposed, intronic splicing...
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BACKGROUND In 2006, the US Food and Drug Administration reorganized the approved label format and content for prescription drugs -also known as the prescribing information (PI). This research examines primary care physicians' use of the new PI and how it may influence their perceptions about prescription drugs. METHODS A total of 500 physicians responded to an Internet survey that displayed a...
متن کاملRepurposing FDA-approved drugs to combat drug-resistant Acinetobacter baumannii.
OBJECTIVE The rising occurrence of drug-resistant pathogens accentuates the need to identify novel antibiotics. We wanted to identify new scaffolds for drug discovery by repurposing FDA-approved drugs against Acinetobacter baumannii, an emerging Gram-negative nosocomial drug-resistant pathogen. MATERIALS AND METHODS In this study, we screened 1040 FDA-approved drugs against drug-susceptible A...
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ژورنال
عنوان ژورنال: International Journal of Applied and Basic Medical Research
سال: 2013
ISSN: 2229-516X
DOI: 10.4103/2229-516x.112228