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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 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.

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 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.

Hot topics

Breast Cancer

Lung Cancer

Liver Cancer

Prostate Cancer

Cancer Treatment

Cancer Screening

Ovarian Cancer

Blood Cancers - Leukemia/Lymphoma/Multiple Myeloma

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.

FDA approves Imfinzi for Extensive-Stage Small Cell Lung Cancer

Additions of the checkpoint inhibitor led to improved survival compared with chemotherapy alone.

Accelerated Approval Granted for Opdivo and Yervoy Combination for Hepatocellular Carcinoma

Efficacy of the combination was investigated in a multicenter, multiple cohort, open-label trial conducted in patients with HCC.

FDA Approves Sarclisa for People With Previously Treated Multiple Myeloma

Approval was based on a study showing combination treatment reduced disease progression or death by 40%.

FDA Approves Nerlynx for Metastatic HER2-Positive Breast Cancer

The efficacy of Nerlynx with capecitabine was investigated in a randomized, multicenter, open-label clinical trial in 621 people.

FDA Requests the Withdrawal of Belviq, Belviq XR (lorcaserin) From the Market

Potential risk of cancer outweighs the benefits

Tazeverik, tazemetostat, epithelioid sarcoma, sarcoma

FDA Approves Tazverik for Soft TIssue Sarcoma

Epithelioid sarcoma is a rare sub-type of soft tissue sarcoma that often occurs in young adults.

Shedding More Light on Sunscreen Absorption

New research adds to our understanding of sunscreens.