EMA 于 2025 年 12 月 22 日授予 Sanofi 的 rilzabrutinib（Wayrilz）欧盟上市授权，用于既往治疗无效的成人免疫性血小板减少症（ITP），并发布 Revision 1 的 EPAR。
关注理由：EMA 发布 rilzabrutinib（Wayrilz）欧盟上市授权 EPAR，含 202 名成人 ITP 随机对照试验数据及 12 周无效停药规则，可用于孤儿药治疗路径跟踪。
原文摘录：This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. … Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program
关注理由：这篇血液病学资料可用于了解领域进展，研究设计、结果和局限性值得一起阅读。