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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 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.

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.

Hot topics

Breast Cancer

Lung Cancer

Liver Cancer

Prostate Cancer

Cancer Treatment

Cancer Screening

Ovarian Cancer

Blood Cancers - Leukemia/Lymphoma/Multiple Myeloma

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.

FDA Approves Tibsovo As First-Line Treatment for AML With IDH1 Mutation

More than 40% of patients with acute myeloid leukemia achieved complete remission.

FDA’s New Efforts to Help Ensure Safety of Breast Implants

The FDA does not believe that, on the basis of all available information, textured implants meets the banning standard.

Mammography: What You Need to Know

The FDA is proposing updates to mammography regulations to reflect advances in technology and processes. How could these changes affect you?

FDA Encourages More Participation, Diversity in Clinical Trials

Overall, few people actually sign up for and participate in trials, and those who do participate don’t always represent the U.S. population.

Fact or Fiction: What to Know About Smoking Cessation and Medications

The FDA wants to help separate fact from fiction to when it comes to methods used to quit smoking.