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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

Weight Management Drug Belviq Possibly Linked to Increased Cancer Risk

A clinical trial shows a possible increased risk of cancer and the FDA is continuing to evaluate the results.

FDA Approves Ayvakit for Metastatic Gastrointestinal Stromal Tumor

Clinical trials showed a high response rate, with almost 85% of participants experiencing tumor shrinkage with this targeted drug.

FDA approves Keytruda for High-Risk Bladder Cancer

In a clinical trial, 46% of responding participants experienced a complete response lasting at least 12 months.

FDA Approves Xtandi for Metastatic Castration-Sensitive Prostate Cancer

The drug was previously approved for castration-resistant prostate cancer.

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.

Office of Hematology Oncology Products Becomes Office of Oncologic Diseases

The reorganization is part of modernization plans that were approved in September 2019.

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

Hot topics

Breast Cancer

Lung Cancer

Liver Cancer

Prostate Cancer

Cancer Treatment

Cancer Screening

Ovarian Cancer

Blood Cancers - Leukemia/Lymphoma/Multiple Myeloma

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.

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.