New Drug Applications

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 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

FDA approves Elacestrant for ER-positive, HER2-negative, ESR1-Mutated Advanced or Metastatic Breast Cancer

On January 27, 2023, the U.S. Food and Drug Administration approved elacestrant for postmenopausal, non-pregnant women and adult men with…

2 years ago

FDA Grants Accelerated Approval to Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma

On January 27, 2023, the U.S. Food and Drug Administration approved Pirtobrutinib for adult patients with histologically confirmed relapsed or…

2 years ago

FDA Approves Pembrolizumab as Adjuvant therapy for Early-stage Resectable Non-small Cell Lung Cancer

On January 26, 2023, the U.S. Food and Drug Administration approved Pembrolizumab for patients with resectable, stage IB (≥4cm)-IIIA (as…

2 years ago

FDA Approves Tucatinib Plus Trastuzumab for RAS Wild-type, HER2+ Metastatic Colorectal Cancer

On January 19, 2023, the U.S. Food and Drug Administration granted accelerated approval to Tucatinib plus Trastuzumab for adult patients…

2 years ago