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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

hand with green ribbon cerebral palsy and liver cancer awareness

FDA Approves Truseltiq for Metastatic Cholangiocarcinoma

New targeted therapy shrank tumors in nearly a quarter of patients with bile duct cancer.

FDA Approves Opdivo for Resected Esophageal Cancer

Checkpoint inhibitor doubled disease-free survival time after surgery.

esophagus, throat, stomach, gastric, digestive tract

FDA Approves Keytruda for HER2-Positive Stomach Cancer

75% of people treated with a combination of immunotherapy, targeted therapy and chemotherapy saw their tumors shrink.

FDA Authorizes First Device that Uses Artificial Intelligence to Help Detect Colon Cancer

The GI Genius aids clinicians in detecting potential irregularities during colon cancer screening and surveillance.

FDA Approves New Targeted Therapy for Lymphoma

Zynlonta led to complete remission in nearly a quarter of patients with large B-cell lymphoma.

FDA Approves Immunotherapy for Endometrial Cancer with Specific Biomarker

New checkpoint inhibitor Jemperli is approved for cancers with deficient mismatch repair mechanism for fixing damaged DNA.

FDA Approves First Immunotherapy for Initial Treatment of Stomach Cancer

Opdivo plus chemotherapy led to a significant improvement in overall survival.

FDA Approves New Sarclisa Regimen for Multiple Myeloma

The monoclonal antibody reduces the risk of disease progression or death by 45%.

Yescarta, CAR-T, axicabtagene ciloleucel

FDA Approves Yescarta for Follicular Lymphoma

The CAR-T therapy led to complete remission in 60% of people with relapsed or refractory follicular lymphoma.

Hot topics

Breast Cancer

Lung Cancer

Liver Cancer

Prostate Cancer

Cancer Treatment

Cancer Screening

Ovarian Cancer

Blood Cancers - Leukemia/Lymphoma/Multiple Myeloma

FDA Approves Lorbrena for Metastatic ALK-Positive Lung Cancer

The targeted therapy delayed disease progression in people with advance non-small-cell lung cancer, including those with brain metastasis.

FDA Approves Pepaxto for Heavily Treated Multiple Myeloma

Nearly a quarter of patients treated with the peptide-drug conjugate experienced partial remission.

FDA Approves Drug to Reduce Bone Marrow Suppression Caused by Chemotherapy

Cosela (trilaciclib) is given before chemotherapy to protect bone marrow function.

FDA Approves Libtayo for Basal Cell Carcinoma

About a quarter of patients with advanced skin cancer experienced tumor shrinkage in a clinical trial.

FDA Approves Ukoniq for Marginal Zone and Follicular Lymphoma

Umbralisib led to remission in 49% of patients with marginal zone lymphoma and 43% of those with follicular lymphoma.

FDA Approves Opdivo Plus Cabometyx for Advanced Kidney Cancer

The immunotherapy combination slowed disease progression and reduced the risk of death by 40%.

FDA Approves Xalkori for Children With Systemic Anaplastic Large Cell Lymphoma

More than 80% of pediatric patients experienced complete remission in a small study.

FDA Approves First Oral Hormone Therapy for Treating Advanced Prostate Cancer

Orgovyx (relugolix) may eliminate some patients’ need to visit a clinic for treatments administered by a health care provider.

FDA Approves First Adjuvant Therapy for Most Common Type of Lung Cancer

Tagrisso (osimertinib) was approved for non-small cell lung cancer patients with EGFR-positive tumors.