New Approvals

FDA Approves HEPZATO KIT for Uveal Melanoma with Unresectable Hepatic Metastases

By Dr. Anish Shah Bronx-Lebanon Hospital   On August 14, 2023, the U.S. Food and Drug Administration approved HEPZATO KIT…

1 year ago

FDA Approves Elranatamab-bcmm for Multiple Myeloma with Relapsed or Refractory Status

By Dr. Anish Shah Bronx-Lebanon Hospital   On August 14, 2023, the U.S. Food and Drug Administration granted accelerated approval…

1 year ago

FDA approves niraparib and abiraterone acetate plus prednisone for metastatic prostate cancer With BRCA Mutation

By Dr. Anish Shah Bronx Lebanon Hospital   On August 11, 2023, the U.S. Food and Drug Administration granted regular…

1 year ago

FDA Approves Talquetamab-Tgvs For Adults with Relapsed Or Refractory Multiple Myeloma Patients with at least Four Prior Lines of Therapy

By Dr. Anish Shah Bronx Lebanon Hospital   On August 9, 2023, the U.S. Food and Drug Administration approved talquetamab-tgvs…

1 year ago

FDA grants approval to Pralsetinib for NSCLC With RET Fusion Mutation

By Dr. Anish Shah Bronx-Lebanon Hospital   On August 9, 2023, the U.S. Food and Drug Administration granted regular approval…

1 year ago

FDA Approves Dostarlimab-gxly for Endometrial Cancer With dMMR or MSI-H Mutation

On July 31, 2023, the U.S. Food and Drug Administration approved dostarlimab-gxly (Jemperli, GlaxoSmithKline) for primary advanced or recurrent endometrial…

1 year ago

FDA Approves Trifluridine and Tipiracil with Bevacizumab for Metastatic Colorectal Cancer (mCRC) with Specific Mutation

On August 2, 2023, the U.S. Food and Drug Administration approved trifluridine and tipiracil (LONSURF) with bevacizumab for the treatment…

1 year ago

FDA Approves Talazoparib and Enzalutamide for Metastatic Castration-Resistant Prostate Cancer with HRR Gene Mutation

On June 20, 2023, the U.S. Food and Drug Administration approved talazoparib (Talzenna, Pfizer, Inc.) in combination with enzalutamide for…

1 year ago

FDA Approves Quizartinib (Vanflyta) for Acute Myeloid Leukemia With FLT3-ITD Mutation

On July 20, 2023, the U.S. Food and Drug Administration (FDA) approved quizartinib (Vanflyta) for adult patients newly diagnosed with…

1 year ago

FDA Grants Accelerated Approval to Glofitamab-gxbm for Relapsed/Refractory DLBCL

On June 15, 2023, the U.S. Food and Drug Administration approved Glofitamab-gxbm (Columvi) for the treatment of adult patients with…

1 year ago