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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 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.

Fred Hutchison, multiple myeloma, bone marrow

FDA Approves Xpovio for Refractory or Relapsed Multiple Myeloma

Xpovio (selinexor) was approved for adults with multiple myeloma who have received at least one prior therapy.

FDA Approves Margenza for Metastatic HER2-Positive Breast Cancer

Monoclonal antibody delays disease progression in people with previously treated HER2-positive tumors.

FDA Approves Gavreto for RET-Altered Thyroid Cancers

Targeted therapy demonstrated high response rates for thyroid tumors with RET mutations or fusions.

FDA Approves High Intensity Focused Ultrasound for Bone Tumors

This technique can relieve pain related to osteoid osteoma.

FDA Grants Accelerated Approval of Danyelza For Neuroblastoma in the Bones

The drug is approved for adults and children with relapsed or refractory neuroblastoma in the bone or bone marrow.

FDA Approves Liquid Biopsy Test For Multiple Cancers and Biomarkers

The blood test identifies biomarkers that could make patients eligible for targeted therapies.

Breast Cancer Screening: Thermogram No Substitute for Mammogram

The Food and Drug Administration re-emphasizes that mammography is still the most effective breast cancer screening test.

Hot topics

Breast Cancer

Lung Cancer

Liver Cancer

Prostate Cancer

Cancer Treatment

Cancer Screening

Ovarian Cancer

Blood Cancers - Leukemia/Lymphoma/Multiple Myeloma

FDA Approves Companion Diagnostic Test for Vitrakvi

The FoundationOne CDx test identifies solid tumors with NTRK fusions.

FDA Grants Regular Approval of Venclexta Regimen For Untreated Acute Myeloid Leukemia

The regimen is approved for adults age 75 or older and those who cannot use intensive induction chemotherapy.

FDA Extends Approval of Keytruda for Classical Hodgkin Lymphoma

The checkpoint inhibitor is approved for adults and children with relapsed lymphoma.

FDA Approves Opdivo Plus Yervoy for Mesothelioma

The immunotherapy combo improved overall survival compared with chemotherapy.

FDA Issues Alert About Tecentriq Plus Paclitaxel for Breast Cancer

A recent clinical trial found that the combination did not work.

FDA Approves Onureg for Acute Myeloid Leukemia

The new drug improved overall survival for people who could not complete curative chemotherapy.

FDA Updates Analysis of Medical Device Reports of Breast Implant Illness and Breast Implant-Associated Lymphoma

The agency also announced the qualification of a tool to aid in the effectiveness assessment of devices used in breast reconstruction.

FDA approves Kyprolis Plus Darzalex Combination for Multiple Myeloma

More than 80% of clinical trial participants experienced complete or partial remission.

FDA Approves First Liquid Biopsy Next-Generation Sequencing Companion Diagnostic Test

Guardant360 identifies patients with EGFR mutations, which could guide treatment decisions.