FDA Approval

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…

9 months 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…

10 months 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…

11 months ago

FDA Grants Accelerated Approval to Epcoritamab for Relapsed or Refractory Diffuse Large B-cell Lymphoma and High-Grade B-cell Lymphoma

On May 19, 2023, Epcoritamab-bysp (Epkinly, Genmab US, Inc) was granted accelerated approval by the US FDA for the treatment…

11 months ago

FDA Grants Approval to Avapritinib for Indolent Systemic Mastocytosis

On May 22, 2023, the U.S. Food and Drug Administration approved avapritinib (Ayvakit) for the treatment of adults with indolent…

11 months ago

FDA Approves Polatuzumab Vedotin-piiq for Previously Untreated Large B-cell Lymphoma

On April 19, 2023, the U.S. Food and Drug Administration (FDA) approved Polatuzumab Vedotin-Piiq in combination with a rituximab product,…

1 year ago

FDA Approves Enfortumab Vedotin with Pembrolizumab for Locally Advanced or Metastatic Urothelial Carcinoma

On April 3, 2023, the U.S. Food and Drug Administration approved enfortumab vedontin-ejfv with pembrolizumab for patients with locally advanced…

1 year ago