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诺华Piqray获批治疗特定类型乳腺癌
新闻中心·21小时以前
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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诺华SMA基因疗法Zolgensma获批
新闻中心·21小时以前
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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中国细胞治疗监管路在何方、诺华两重磅产品获批上市、...
新闻中心·22小时以前
每日要闻
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李氏大药厂附属眼科公司完成5000万美元A轮融资
新闻中心·22小时以前
China ophthalmology完成A轮融资
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首个双胰岛素诺和佳在中国获批
新闻中心·22小时以前
德谷门冬双胰岛素已在全球26个国家和地区上市
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Synlogic与罗氏合作开发SYNB1891+atezolizumab 联合方...
新闻中心·22小时以前
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授予Iovance的TIL产品LN-145突破性疗法认证
新闻中心·22小时以前
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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杨森递交INVOKANA治疗并发肾病糖尿病的补充申请
新闻中心·22小时以前
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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FDA批准Novocure 电场疗法治疗恶性间皮瘤
新闻中心·22小时以前
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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中国细胞治疗监管路在何方 | 研发客年会
程昊红·2019-05-24
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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