WebPfizer Inc. today announced the voluntary withdrawal from the U.S. market of the drug Mylotarg (gemtuzumab ozogamicin) for patients with acute myeloid leukemia (AML), a … WebAug 27, 2024 · Atezolizumab TNBC Indication Withdrawn By Manufacturer After Talks With FDA Aug 27, 2024 Hayley Virgil Atezolizumab will no longer be available for the treatment of patients with PD-L1–positive triple-negative breast cancer following withdrawal of the indication by the agent’s developer.
Genentech Withdraws Breast Cancer Indication From Tecentriq
WebJun 1, 2024 · The U.S. Food and Drug Administration said on Wednesday it has withdrawn its approval for TG Therapeutics Inc's lymphatic cancer treatment Ukoniq over concerns of higher risk of death in patients receiving the drug. Ukoniq received accelerated approval in the United States in February last year to treat adult patients with marginal zone ... WebFeb 23, 2024 · In proposing to withdraw the drug, CDER cited the failed confirmatory trial as well as the “integrity” of the accelerated approval process. (Also see “Accelerated Approval: US FDA Request For Makena’s Withdrawal Goes Beyond Failed Confirmatory Trial” – Pink Sheet, 5 Oct, 2024.) Opdivo Holds New Record For Time To Removal fantasy natural resources
Merck withdraws Keytruda for lung cancer amid FDA crackdown
WebMar 28, 2024 · The withdrawal does not affect FDA-approved uses of atezolizumab for the treatment of other cancers. On March 8, the Food and Drug Administration (FDA) granted an accelerated approval for the immunotherapy drug atezolizumab (Tecentriq) in combination with chemotherapy for the initial treatment of some women with advanced … WebIncreased risks of death have led three groups of oncology drugmakers to withdraw their PARP inhibitors in heavily pretreated ovarian cancer patients. In a decision that has … WebMar 8, 2024 · The indication for atezolizumab (Tecentriq) in patients with urothelial carcinoma who have previously received platinum-based chemotherapy has been withdrawn in the United States, according to the drug’s developer, Roche. 1. The decision was made in consultation with the FDA and is part of an industry-wide assessment of … cornwall mls listings ontario