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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 Approves New Therapy for Myelodysplastic Syndromes (MDS) That Can Be Taken at Home

This represents an important advance in treatment options for patients with MDS who previously needed to visit a health care facility.

FDA Program Will Communicate Patient Reported Outcomes from Cancer Clinical Trials

Project Patient Voice is going to provide patient-reported symptoms from cancer trials for marketed treatments.

esophagus, throat, stomach, gastric, digestive tract

FDA Approves Opdivo for Esophageal Cancer

Checkpoint inhibitor extended survival by about three months compared with chemotherapy.

FDA Approves Cyramza Plus Tarceva for First-Line Lung Cancer Treatment

Ramucirumab slowed disease progression more than a placebo when added to erlotinib.

FDA Approves Opdivo Plus Yervoy With Chemotherapy for Metastatic Lung Cancer

Adding the immunotherapy combination improved survival compared with chemotherapy alone.

FDA Approves Alunbrig for ALK-Positive Metastatic Non-Small-Cell Lung Cancer

Study showed 74% overall response rate for people who used brigatinib as their first ALK inhibitor.

FDA Approves Qinlock for Fourth-Line Treatment of Advanced Gastrointestinal Stromal Tumors

New targeted therapy delayed disease progression compared with a placebo.

FDA Approves Tecentriq for First-Line Treatment of Metastatic Lung Cancer

Initial treatment with atezolizumab led to longer overall survival in people with high biomarker levels.

FDA Approves Opdivo Plus Yervoy for Lung Cancer With PD-L1 Expression

The combination led to improved overall survival compared with chemotherapy.

Hot topics

Breast Cancer

Lung Cancer

Liver Cancer

Prostate Cancer

Cancer Treatment

Cancer Screening

Ovarian Cancer

Blood Cancers - Leukemia/Lymphoma/Multiple Myeloma

FDA Approves Lynparza Plus Bevacizumab for Ovarian Cancer Maintenance Treatment

The PARP inhibitor delayed disease progression by 20 months compared with a placebo.

FDA Approves Tabrecta for Metastatic Non-Small Cell Lung Cancer

Capmatinib shrank tumors in 68% of people with metastatic non-small-cell lung cancer with a specific MET mutation.

FDA Approves Injectable Formulation of Darzalex for Multiple Myeloma

Darzalex Faspro can be given by subcutaneous injection rather than IV infusion.

FDA Approves Zejula For First-Line Maintenance of Advanced Ovarian Cancer

Zejula delayed disease progression in people with advanced ovarian cancer who had a complete or partial response to platinum chemotherapy.

FDA Approves Imbruvica Plus Rituxan for Chronic Lymphocytic Leukemia

Imbruvica plus Rituxan delayed disease progression when compared with a triple chemotherapy regimen.

FDA Approves Jelmyto for Upper Tract Urothelial Cancer

More than half of patients treated with mitomycin experienced complete tumor remission.

FDA Approves Koselugo for Pediatric Neurofibromatosis

The kinase inhibitor is the first approved treatment for children with this rare disease.

FDA Approves Braftovi Combination for Metastatic Colon Cancer

Encorafenib plus cetuximab improved survival in a Phase III study.

FDA Requests Removal of All Ranitidine Products (Zantac) from the Market

FDA advises consumers, patients and health care professionals after new FDA studies show risk to public health.