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FDA Approvals

FDA Accelerated the Approval of Akeega, First and Only Dual-Action Tablet for Metastatic Prostate Cancer With BRCA Mutation

FDA Granted Accelerated Approval to Elrexfio, a Bispecific BCMA-Directed CD3 T-Cell Engager, for Relapsed or Refractory MM

Hepzato Kit FDA Approved as a Liver-Directed Treatment for Uveal Melanoma With Hepatic Metastases

Gavreto Received Regular FDA Approval for Patients With Non–Small Cell Lung Cancer and RET Gene Fusion

Lonsurf Received a New Indication, in Combination With Bevacizumab, for Previously Treated Metastatic Colorectal Cancer

Jemperli Plus Chemotherapy Now FDA Approved for Front-Line Treatment of dMMR or MSI-H Endometrial Cancer

Vanflyta Now Approved for Newly Diagnosed FLT3-ITD–Positive AML

Talzenna Received a New Indication, With Enzalutamide, for Metastatic Castration-Resistant Prostate Cancer With HRR Gene Mutation

Nubeqa Now Indicated for Metastatic Hormone-Sensitive Prostate Cancer

Imfinzi Receives New FDA Indication for Advanced or Metastatic Biliary Tract Cancer

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