이 기사의 번역을 준비하고 있습니다. 그동안 영어 원문을 임시로 표시합니다.
비즈니스 · 2022. 5. 26.1 분 읽기
Gilead Sciences, Inc.; Withdrawal of Approval of Indications for Relapsed Follicular Lymphoma and Relapsed Small Lymphocytic Lymphoma for ZYDELIG (Idelalisib) Tablets
로컬 자동 번역 · 원본 출처 언어
요약
The Food and Drug Administration (FDA or Agency) is announcing that it is withdrawing approval of the indications for relapsed follicular lymphoma and relapsed small lymphocytic lymphoma for ZYDELIG (idelalisib) Tablets, approved under new drug application (NDA) 205858, held by Gilead Sciences, Inc., 333 Lakeside Dr., Foster City, CA 94404 (Gilead). Gilead voluntarily requested that the Agency withdraw approval of these indications and waived its opportunity for a hearing.
원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →