New Approvals

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…

1 year 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…

1 year 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,…

2 years 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…

2 years ago

FDA Approves Pembrolizumab for Solid Tumors with MSI-H or dMMR Mutations for Select Patients

On March 29, 2023, the U.S. Food and Drug Administration approved pembrolizumab for adult and pediatric patients with unresectable or…

2 years ago

FDA Approves Retifanlimab-dlwr for Metastatic or Recurrent Locally Advanced Merkel Cell Carcinoma

On March 22, 2023, the U.S. Food and Drug Administration granted accelerated approval to retifanlimab-dlwr — a humanized monoclonal antibody…

2 years ago

FDA Approves Dabrafenib with Trametinib for Pediatric Patients with Low-Grade Glioma (LGG), a BRAF V600E Mutation

On March 16, 2023, the U.S. Food and Drug Administration approved dabrafenib and trametinib for pediatric patients 1 year of…

2 years ago

FDA Approves an Expanded Indication of Abemaciclib with Endocrine Therapy for Early Breast Cancer

On March 4, 2023, the U.S. Food and Drug Administration approved expanded use of adjuvant abemaciclib with endocrine therapy for…

2 years ago

FDA Grants Regular Approval to Dostarlimab-gxly for dMMR Endometrial Cancer

On February 9th, 2023, the U.S. Food and Drug Administration approved dostarlimab-gxly for adult patients with recurrent or advanced endometrial…

2 years ago

FDA Approves Sacituzumab Govitecan-hziy for HR+/HER2- Metastatic Breast Cancer

On February 3, 2023, the U.S. Food and Drug Administration approved sacituzumab govitecan-hziy for women 18 years or older with…

2 years ago