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Imprese · 26/05/20221 min di lettura
Gilead Sciences, Inc.; Withdrawal of Approval of Indications for Relapsed Follicular Lymphoma and Relapsed Small Lymphocytic Lymphoma for ZYDELIG (Idelalisib) Tablets
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Riepilogo
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.
Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →