原始出處紀錄
決策級FDA 仿單更新
Regeneron：FDA 核准 EYLEA HD 用於 RVO 及每月給藥彈性
FDA 已核准 EYLEA HD 用於 RVO 後黃斑部水腫，以及所有已核准適應症的每月給藥。一家新製造商也已獲核准填充 EYLEA HD 藥瓶，而同一製造商填充預充填注射器的法規申請預計於 2026 年第二季做出決定。
關鍵事實
- 申報時間
- 2026年1月30日 上午11:51
- 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 exhibit991q42025.htm EXHIBIT 99.1 Document Exhibit 99.1 Press Release Regeneron Reports Fourth Quarter and Full Year 2025 Financial and Operating Results • Fourth quarter 2025 revenues increased 3% to $3.9 billion versus fourth quarter 2024; full year 2025 revenues increased 1% to $14.3 billion versus 2024 • Fourth quarter 2025 Dupixent ® global net sales (recorded by Sanofi) increased 34% to $4.9 billion versus fourth quarter 2024; full year 2025 Dupixent global net sales increased 26% to $17.8 billion versus 2024 • Fourth quarter 2025 EYLEA HD ® U.S. net sales increased 66% to $506 million and total EYLEA HD and EYLEA ® U.S. net sales decreased 28% to $1.1 billion; full year 2025 EYLEA HD U.S. net sales increased 36% to $1.6 billion and total EYLEA HD and EYLEA U.S. net sal