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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

Diffuse Large B-cell Lymphoma Lymphoma, Myeloma, Leukemia, Lymphocyte, Tumor

FDA Approves Epkinly for Advanced B-Cell Lymphoma

The overall response rate was 61% for patients treated with the bispecific T-cell engager.

FDA Approves Omisirge to Speed Neutrophil Recovery in Blood Cancer Patients

Omidubicel led to faster neutrophil recovery following umbilical cord blood transplantation.

FDA Approves Zynyz for Merkel Cell Carcinoma

Half of patients with this rare skin cancer experienced tumor shrinkage when treated with the new checkpoint inhibitor.

FDA Approves Orserdu for Certain Patients With HER2-Negative Advanced Breast Cancer

Orserdu (elacestrant) is the first treatment for people with ESR1 mutations, which can drive resistance to standard hormone therapy.

FDA Approves to Jaypirca Targeted Therapy for Mantle Cell Lymphoma

Jaypirca (pirtobrutinib) is a highly selective kinase inhibitor that utilizes a novel binding mechanism.

FDA Approves First Gene Therapy for High-Risk Bladder Cancer

Half of patients treated with the adenovirus vector-based gene therapy Adstiladrin experienced complete remission.

FDA Approves Pepaxto for Heavily Treated Multiple Myeloma

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

FDA Grants Accelerated Approval to Futibatinib (Lytgobi) for Cholangiocarcinoma

Cholangiocarcinoma is a rare cancer of the bile ducts that is often diagnosed late and can progress rapidly.

FDA Issues Safety Alert for Cancers in Scar Tissue Around Breast Implants

Squamous cell carcinoma and lymphomas have been reported in the scar tissue of breast implants, but the FDA believes the risk is rare.

Hot topics

Breast Cancer

Lung Cancer

Liver Cancer

Prostate Cancer

Cancer Treatment

Cancer Screening

Ovarian Cancer

Blood Cancers - Leukemia/Lymphoma/Multiple Myeloma

FDA Approves Yescarta for Second-Line Treatment of Large B-cell Lymphoma

The personalized CAR-T therapy prolonged cancer remission compared with standard therapy.

FDA Approves Pluvicto For Metastatic Castration-Resistant Prostate Cancer

The radiopharmaceutical was approved for previously treated adults with PSMA-positive metastatic prostate cancer.

FDA Approves Tecartus CAR-T Therapy for Acute Lymphoblastic Leukemia

Half of patients treated with the customized T cells achieved complete remission.

FDA Strengthens Safety Requirements and Updates Study Results for Breast Implants

The agency adds restrictions and approves new labeling for all approved breast implants.

FDA Approves New Medication for Chronic Myeloid Leukemia

Scemblix was approved for certain patients with Philadelphia chromosome-positive chronic myeloid leukemia.

FDA Approves Cabometyx for Differentiated Thyroid Cancer

The targeted therapy delayed disease progression or death by approximately nine months.

Secondhand (and Third-Hand) Smoke Increases Your Pet’s Cancer Risk

Did you know? A cat who lives with a pack-a-day smoker is three times more likely to develop lymphoma.

FDA Approves Welireg for Cancers Associated With Von Hippel-Lindau Disease

Welirge (belzutifan) is approved for people who require therapy for associated renal cell carcinoma or other malignancies.

FDA Approves Lenvima Plus Keytruda for Advanced Kidney Cancer

Targeted therapy and immunotherapy combination doubles response rate for people with advanced renal cell carcinoma.