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早些时候报道,Innoviva Specialty Thereutics报告了III期Zoliflodacin结果发表在《柳叶刀》上,FDA NDA于2025年6月和12月接受PDUFA目标
2025-12-12 16:25
- Phase 3 findings show oral zoliflodacin to be non-inferior to the combination of ceftriaxone and azithromycin for the treatment of uncomplicated urogenital gonorrhea.
- Positive study results are a significant milestone in the development of a first-in-class single-dose, oral antibiotic against gonorrhea, including infections caused by drug-resistant Neisseria gonorrhoeae, an urgent public health threat and high-priority pathogen.
- Gonorrhea is the second most reported bacterial STI in the United States, with resistance to first-line treatment emerging.
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