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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 Treatment for Mantle Cell Lymphoma

Clinical trials showed that 84% of patients saw tumor shrinkage with this therapy.

FDA Reorganizes Office That Reviews Cancer Treatments

The plan aims to streamline evaluation of increasingly complex therapies for these life-threatening diseases.

Men With Breast Cancer Need More Treatment Options and Access to Genetic Counseling

One reason for late-age (and later stage) diagnosis may be that men and their doctors don’t think of themselves as being at risk.

What to Know About Breast Implants

Implants are extensively tested before approval to demonstrate safety and effectiveness. Still, there are risks associated with all implants

FDA Approves Zejula for Advanced Ovarian Cancer in People With Faulty DNA Repair Genes

The indication is for people with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with prior chemotherapy regimens.

FDA Approves Darzalex for Transplant-Eligible Multiple Myeloma

The approval is based on data from CASSIOPEIA, an open-label, randomized, active-controlled phase 3 study.

U.S., Australia and Canada Simultaneously Approve Combo for Endometrial Cancer

Keytruda plus Lenvima is first approval under Project Orbis collaboration.

Statement Alerting Patients and Health Care Professionals of NDMA Found in Samples of Ranitidine

The FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines.

FDA Issues Warning About Ibrance, Kisqali, Verzenio Due to Lung Inflammation

The FDA is warning that these drugs used to treat advanced breast cancers may cause rare but severe inflammation of the lungs.

Hot topics

Breast Cancer

Lung Cancer

Liver Cancer

Prostate Cancer

Cancer Treatment

Cancer Screening

Ovarian Cancer

Blood Cancers - Leukemia/Lymphoma/Multiple Myeloma

FDA Approves Inrebic (Fedratinib) for Myelofibrosis

This is the second drug the FDA has approved for myelofibrosis; the first came in 2011.

FDA Approves First Therapy for Rare Joint Tumor

Though seldom malignant, tenosynovial giant cell tumors can damage joints and tendons.

FDA approves Keytruda for advanced esophageal squamous cell cancer

pembrolizumab’s efficacy was investigated in two clinical trials of people with recurrent, locally advanced or metastatic disease.

FDA Approves Darzalex (Daratumumab) for Multiple Myeloma

Darzalex in combination with lenalidomide and dexamethasone is for people who are ineligible for an autologous stem cell transplant.

Safety Alert: Fecal Microbiota for Transplantation and Risk of Transmission of Multi-Drug Resistant Organisms

An immunocompromised patient died from invasive infections after an investigational fecal microbiota transplant.

Doctors and researches illustration with microscope, beaker and test tubes

FDA’s Project Facilitate Will Help Providers Access Experimental Cancer Therapies for Patients

New initiative will help health care providers navigate the process of submitting expanded access requests.

Tips to Stay Safe in the Sun: From Sunscreen to Sunglasses

People of all skin colors are potentially at risk for sunburn and other harmful effects of UV radiation, so always protect yourself.

FDA Approves Revlimid for Follicular and Marginal Zone Lymphoma

Approval was based on the results of two clinical trials: AUGMENT and MAGNIFY.

FDA Approves Venclexta for Certain Types of Leukemia and Lymphoma

Study found Venclexta plus Gazyva (obinutuzumab) delayed disease progression in previously untreated patients.