Regulatory Actions
This article reviews the proposed mechanisms of action of venetoclax in AML and the potential future of venetoclax in AML.
Allogene Therapeutics has been cleared by the U.S. Food and Drug Administration (FDA) to resume trials of its allogeneic ...
After failing to complete the requisite confirmatory trials following accelerated approval, Gilead has announced it will ...
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The trial was placed on hold after Kura Oncology reported a grade 5 serious adverse event resulting in a patient’s death.
BNT200 is intended for the treatment of anxiety and depression in hospitalized adults with AML.
Director of the U.S. Food and Drug Administration’s (FDA’s) Oncology Center of Excellence Richard Pazdur, MD, has ...
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The FDA has approved an update to the prescribing information for all approved indications of axi-cel.
NKX101 is an immunotherapy that uses natural killer cells from the peripheral blood of healthy donors.
Abatacept has been U.S. Food and Drug Administraion (FDA)-approved as acute graft-versus-host disease (aGVHD) prophylaxis for ...
Daratumumab and hyaluronidase-fihj, in combination with carfilzomib and dexamethasone (Kd), has received U.S. Food and Drug ...
The U.S. Food and Drug Administration (FDA) granted orphan drug designation (ODD) to nanatinostat and valganciclovir for the ...
Approval is based on efficacy data from the Inter-B-NHL Ritux 2010 study.
Current study participants may continue to be treated with KO-539.
The guidance is based on expert opinion and current limited data relating to vaccination in patients with active malignancy.
On March 31, 2021, the FDA extended the indication of isatuximab for use in combination with carfilzomib and dexamethasone ...
The U.S. Food and Drug Administration (FDA) approved idecabtagene vicleucel (ide-cel) for the treatment of adults with ...
On March 1, 2021, the U.S. Food and Drug Administration granted accelerated approval to melphalan flufenamide (melflufen) in ...
The new recommendations were published in Blood Cancer Discovery.
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