June 23, 2023

Ongoing | Cancer Accelerated Approvals

Columvi (glofitamab-gxbm) Relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified or large B-cell lymphoma arising from follicular lymphoma, after two or more lines of […]
June 22, 2023

List of Determinations Including Written Request

Drug Sponsor Determination Date Written Request and Related Documents Abacavir/ dolutegravir/ lamivudine ViiV Healthcare Company 6/7/2023 Abatacept BMS 2/14/2017  Acetaminophen Mallinckrodt 7/11/2016 Afatinib  Boehringer Ingelheim Pharmaceuticals, […]
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