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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

Yescarta, CAR-T, axicabtagene ciloleucel

FDA Approves Yescarta for Follicular Lymphoma

The CAR-T therapy led to complete remission in 60% of people with relapsed or refractory follicular lymphoma.

FDA Approves Lorbrena for Metastatic ALK-Positive Lung Cancer

The targeted therapy delayed disease progression in people with advance non-small-cell lung cancer, including those with brain metastasis.

FDA Approved Pepaxto for Heavily Treated Multiple Myeloma

Nearly a quarter of patients treated with the peptide-drug conjugate experienced partial remission.

FDA Approves Drug to Reduce Bone Marrow Suppression Caused by Chemotherapy

Cosela (trilaciclib) is given before chemotherapy to protect bone marrow function.

FDA Approves Libtayo for Basal Cell Carcinoma

About a quarter of patients with advanced skin cancer experienced tumor shrinkage in a clinical trial.

FDA Approves Ukoniq for Marginal Zone and Follicular Lymphoma

Umbralisib led to remission in 49% of patients with marginal zone lymphoma and 43% of those with follicular lymphoma.

FDA Approves Opdivo Plus Cabometyx for Advanced Kidney Cancer

The immunotherapy combination slowed disease progression and reduced the risk of death by 40%.

FDA Approves Xalkori for Children With Systemic Anaplastic Large Cell Lymphoma

More than 80% of pediatric patients experienced complete remission in a small study.

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.

Hot topics

Breast Cancer

Lung Cancer

Liver Cancer

Prostate Cancer

Cancer Treatment

Cancer Screening

Ovarian Cancer

Blood Cancers - Leukemia/Lymphoma/Multiple Myeloma

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.

FDA Approves Companion Diagnostic Test for Vitrakvi

The FoundationOne CDx test identifies solid tumors with NTRK fusions.