原始出處紀錄
決策級FDA 仿單更新
Incyte：FDA 核准 Opzelura sNDA 用於小兒異位性皮膚炎
FDA 核准 Opzelura（ruxolitinib cream）補充性新藥申請，用於短期及非連續性慢性治療非免疫功能低下、年滿兩歲及以上輕度至中度異位性皮膚炎患者。更新後的仿單已納入疾病未以局部處方藥物控制良好、或不建議使用該等藥物的 ≥2 歲兒科患者。
關鍵事實
- 申報時間
- 2025年10月28日 上午11:04
- 事件
- FDA 仿單更新
- 方向
- 正面
- 來源
- SEC 8-K
- 可信度
- 有出處
來源摘錄
EX-99.1 2 incy-q32025xexx991.htm EX-99.1 Document Exhibit 99.1 FOR IMMEDIATE RELEASE Incyte Reports Third Quarter 2025 Financial Results and Provides Business Updates Total revenues of $1.37 billion in the third quarter of 2025, reflecting 20% growth compared to the third quarter of 2024 Jakafi ® (ruxolitinib) net product revenue of $791 million, an increase of 7% compared to the same period in 2024 Opzelura ® (ruxolitinib) cream net product revenue of $188 million, an increase of 35% compared to the prior year period Hematology-Oncology portfolio net product revenues of $171 million, including Niktimvo ™ (axatilimab-csfr) net revenue of $46 million Raises 2025 full year net product revenue guidance to $4.23 - $4.32 billion Conference Call and Webcast Scheduled Today at 8:00 a.m. ET WI