原始来源记录
决策级FDA 批准
BioCryst：FDA批准ORLADEYO口服颗粒剂用于儿科HAE
FDA批准了每日一次ORLADEYO（贝罗曲他）口服颗粒剂新药申请，用于2至<12岁儿童遗传性血管性水肿的预防性治疗。此举将获批适应症从成人/青少年扩展至该儿科人群，成为首个且唯一的口服预防性治疗选择。
关键事实
- 申报时间
- 2025年12月12日 12:51
- 事件
- FDA 批准
- 方向
- 积极
- 来源
- SEC 8-K
- 可信度
- 有来源
来源摘录
Form 8-K False 0000882796 0000882796 2025-12-12 2025-12-12 iso4217:USD xbrli:shares iso4217:USD xbrli:shares UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _________________ FORM 8-K _________________ CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): December 12, 2025 _______________________________ BioCryst Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) _______________________________ Delaware 000-23186 62-1413174 (State or Other Jurisdiction of Incorporation) (Commission File Number) (I.R.S. Employer Identification No.) 4505 Emperor Blvd., Suite 200 Durham , North Carolina 27703 (Address of Principal Executive Offices) (Zip Code) ( 919 ) 859-1302 (