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Piqray plus fulvestrant nearly doubled median PFS (11.0 vs 5.7 months) in HR+/HER2- advanced breast cancer patients with a PIK3CA mutation compared to fulvestrant alone
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Data from the Phase 3 STR1VE trial show prolonged event-free survival, increases in motor function and significant milestone achievement in patients with SMA Type 1
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Synlogic expects to file an IND application with the FDA in the second half of 2019 for SYNB1891 to enable the company to begin an open-label Phase 1 clinical trial to evaluate the candidate as a monotherapy and a combination treatment with atezolizumab
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FDA has granted Breakthrough Therapy designation to Iovance TIL therapy candidate LN-145 in recurrent, metastatic, or persistent cervical cancer with disease progression on or after chemotherapy
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If approved, INVOKANA will be the first and only therapy in nearly 20 years indicated to reduce the risk of kidney failure when added to current standard of care
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In the STELLAR trial, malignant pleural mesothelioma patients treated with Tumor Treating Fields plus platinum-based chemotherapy experienced a median overall survival of 18.2 months
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作为有着更高风险，要求更严格、更规范质量把控的领域，规范的监管路径对整个行业的规范、创新、发展起着举足轻重的作用。
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