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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 of Bizengri for Lung and Pancreatic Cancer

Zenocutuzumab, a bispecific antibody, is indicated for non-small-cell lung cancer and pancreatic adenocarcinoma with NRG1 gene fusions.

Hepatologist doctor, liver specialist. Aesthetic handdrawn highlighted illustration of human liver.

FDA Grants Accelerated Approval of Ziihera for HER2-Positive Biliary Tract Cancer

Zanidatamab, a bispecific antibody, is indicated for previously treated unresectable or metastatic bile duct or gallbladder cancer.

esophagus, throat, stomach, gastric, digestive tract

FDA Approves Vyloy for Advanced Stomach Cancer

Zolbetuximab is a monoclonal antibody targeting claudin 18.2, a protein expressed on gastric and gastroesophageal junction tumors.

FDA Approves New Targeted Therapy for Brain Cancer

Voranigo was approved for astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation.

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.

Hot topics

Breast Cancer

Lung Cancer

Liver Cancer

Prostate Cancer

Cancer Treatment

Cancer Screening

Ovarian Cancer

Blood Cancers - Leukemia/Lymphoma/Multiple Myeloma

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.

FDA Approves Unloxcyt for Cutaneous Squamous Cell Carcinoma

New PD-L1 checkpoint inhibitor is indicated for people with metastatic or locally advanced cancer who are not eligible for curative therapy.

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.