Quizartinib Plus Chemo Gains FDA Approval for Newly Diagnosed, FLT3-ITD+ AML
July 21st 2023Quizartinib has been approved by the FDA for use with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy after consolidation chemotherapy, to treat adults with newly diagnosed acute myeloid leukemia that is FLT3-ITD positive, as detected by an FDA-approved test.
Zolbetuximab BLA Undergoes Priority Review for CLDN18.2+ Advanced Gastric/Gastroesophageal Cancer
July 11th 2023The FDA has granted priority review to the biologics license application for zolbetuximab as a treatment for patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.
FDA Approves Radiohybrid PET Diagnostic Agent Posluma for PSMA-Positive Lesions in Prostate Cancer
May 30th 2023The PET diagnostic imaging agent, flotufolastat F 18 injection has been approved by the FDA for the identification of prostate-specific membrane antigen–positive lesions in men with prostate cancer