原始出處紀錄
重大PDUFA 日期確定
Gilead：FDA 為 BIC/LEN NDA 設定 PDUFA 日期 2026 年 8 月 27 日
FDA 已接受 BIC/LEN 的 NDA 並給予優先審查。該機構指定 PDUFA 目標行動日期為 2026 年 8 月 27 日，為此單錠方案在病毒學抑制 HIV 患者中的監管時間表確立。
關鍵事實
來源摘錄
EX-99.1 2 exhibit991earningspressrel.htm EXHIBIT 99.1 Document GILEAD SCIENCES ANNOUNCES FIRST QUARTER FINANCIAL RESULTS Product Sales Excluding Veklury Increased 8% Year-Over-Year to $6.8 billion Biktarvy Sales Increased 7% Year-Over-Year to $3.4 billion Foster City, CA, May 7, 2026 - Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the first quarter 2026. “Gilead teams have delivered another strong quarter with 8% year-over-year growth in our base business and 10% growth in HIV, supported by the successful launch of Yeztugo. We have raised our full year revenue guidance as a reflection of our performance," said Daniel O’Day, Gilead’s Chairman and Chief Executive Officer. “Building on the strongest pipeline in Gilead’s history, we are adding potentially