FDA
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今晚8点！百济PD-1面临FDA大考
国产PD-1再临FDA大考，此次胜算几何？ 2022年2月，信达/礼来携PD-1信迪利单抗初征FDA 肿瘤药物咨询委员会（ODAC），最终结果以“ORIENT-11不是一个国际多中…
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首款！FDA批准强生IL-23抗体新适应症
强生猛攻IBD（炎症性肠病）领域，一年两次向FDA递交上市申请。 一次在今年三月，强生向FDA递交旗下Tremfya（古塞奇尤单抗），用于中重度活动性溃疡性结肠炎（UC）成人患者的…
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First! FDA approves new indication for Johnson & Johnson’s IL-23 antibody
Congratulations to Johnson & Johnson!
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In the midst of a market downturn, with a year-on-year sales increase of 50%, what did this biopharma do right?
A Biopharma with outstanding product innovation and internal adjustment capabilities has no reason not to navigate through the cycle
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The fatal monkeypox outbreak is re-emerging, are the investigational drugs proven to be ineffective?
DrugTime team will follow up on this key subject. Please stay tuned
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Celine Dion, the legendary pop diva, is waiting for a CAR-T therapy?
All our best wishes! We will continue to provide our assistance to drug discovery and development with full effort
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19款FDA批准的基因疗法
根据2024年7月12日CBER主任Peter Marks博士的演讲和公开信息准备
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秀发重回！FDA批准的「斑秃」新药，安全性怎么样？
2024年7月25日，印度第一大制药公司Sun Pharmaceutical 宣布FDA批准了Leqselvi（deuruxolitinib）一日两次8mg片剂用于治疗成人重度斑秃…
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How to Maximize the Value of Innovative Drugs When Going Global? Former FDA and EMA Experts from Parexel Reveal the Best Plan
13 seasoned experts shared rather valuable information for 4 hours
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Sarepta Therapeutics Announces Expanded US FDA Approval of ELEVIDYS to Duchenne Muscular Dystrophy Patients Ages 4 and Above
Congratulations to Sarepta Therapeutics and DMD patients!
