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Overview

Food and Drug Administration (FDA)

The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.

Articles

FDA Grants Accelerated Approval to Imdelltra for Extensive Stage Small-Cell Lung Cancer

Tarlatamab, a bispecific T-cell engager, had an overall response rate of 40% in patients who progressed after chemotherapy.

FDA Approves Ojemda for Children With Relapsed or Refractory Brain Tumors

Half of pediatric patients treated with tovorafenib experienced tumor shrinkage.

FDA Approves Jaypirca For Chronic Lymphocytic Leukemia

Nearly three quarters of treated patients experienced partial disease regression.

FDA Approves Iwilfin for High-Risk Neuroblastoma

Eflornithine is the first FDA-approved therapy to reduce the risk of relapse in children with high-risk neuroblastoma.

FDA Approves Ogsiveo for Desmoid Tumors

Patients receiving nirogacestat had delayed disease progression and reported less pain.

Photo about Radiology technician examens mammography test. Image of technician, horizontal, radiology

FDA Approves Truqap for Breast Cancer

Capivasertib/fulvestrant combo is approved for patients with HR-positive/HER2-negative advanced breast cancer with specific mutations.

FDA Approves Augtyro for ROS1-Positive Non-Small-Cell Lung Cancer

Repotrectinib led to tumor shrinkage in 79% of patients who had not previously used a tyrosine kinase inhibitor.

FDA Approves Loqtorzi for Nasopharyngeal Carcinoma

Toripalimab plus chemotherapy led to improvement in progression-free and overall survival.

FDA Approves Fruzaqla for Refractory Metastatic Colorectal Cancer

Fruquintinib improved progression-free and overall survival for patients who did not respond to chemotherapy.

Hot topics

Breast Cancer

Lung Cancer

Liver Cancer

Prostate Cancer

Cancer Treatment

Cancer Screening

Ovarian Cancer

Blood Cancers - Leukemia/Lymphoma/Multiple Myeloma

Cancer cell - antibodies stock photo Antibody, Cancer Cell, Three Dimensional, Cancer

FDA Grants Accelerated Approval to Elrexfio for Multiple Myeloma

The new bispecific T-cell engager is approved for people who have received at least four prior lines of treatment.

illustration of human body showing liver

FDA Approves Melphalan as a Liver-Directed Treatment for Uveal Melanoma

Hepato Kit was approved for patients with uveal melanoma that has spread to the liver.

woman holding model male reproductive system

FDA Approves Akeega for Metastatic Prostate Cancer

Patients taking the combination with prednisone saw an improvement in progression-free survival.

FDA Approves Talvey for Relapsed or Refractory Multiple Myeloma

Talquetamab is indicated for patients who have tried at least four prior lines of treatment.

FDA Approves Vanflyta for Newly Diagnosed Acute Myeloid Leukemia

Trial showed that treatment with quizartinib led to a significant improvement in overall survival.

FDA Approves Columvi for Large B-Cell Lymphomas

More than 40% of patients treated with the bispecific T-cell engager experienced complete remission.

Diffuse Large B-cell Lymphoma Lymphoma, Myeloma, Leukemia, Lymphocyte, Tumor

FDA Approves Epkinly for Advanced B-Cell Lymphoma

The overall response rate was 61% for patients treated with the bispecific T-cell engager.

FDA Approves Omisirge to Speed Neutrophil Recovery in Blood Cancer Patients

Omidubicel led to faster neutrophil recovery following umbilical cord blood transplantation.

FDA Approves Zynyz for Merkel Cell Carcinoma

Half of patients with this rare skin cancer experienced tumor shrinkage when treated with the new checkpoint inhibitor.