この記事の翻訳を準備しています。それまでの間、英語の原文を表示します。
ビジネス · 2022/4/131 分で読めます
Secura Bio, Inc.; Withdrawal of Approval of Relapsed or Refractory Follicular Lymphoma Indication for COPIKTRA
ローカル自動翻訳 · 情報源の原言語
概要
The Food and Drug Administration (FDA) is announcing that it is withdrawing approval of the relapsed or refractory follicular lymphoma indication for COPIKTRA (duvelisib) Capsules, approved under new drug application 211155, held by Secura Bio, Inc., 1995 Village Center Circle, Suite 128, Las Vegas, NV 89134. Secura Bio, Inc. voluntarily requested that the Agency withdraw approval of this indication and has waived its opportunity for a hearing.
情報源の原言語: Federal Register — Food and Drug Administration原文の発表を開く →