FDA News

FDA Clears Narrow Band Imaging for Bladder Cancer

FDA Clears Narrow Band Imaging for Bladder Cancer

NBI visualized non-muscle-invasive bladder cancer lesions in 17% more patients and 24% more tumors than white light.

Dulaglutide Approved for Type 2 Diabetes

Dulaglutide Approved for Type 2 Diabetes

Once-weekly subcutaneous injection of Trulicity (dulaglutide), a glucagon-like peptide-1 receptor agonist.

Jardiance Approved for Type 2 Diabetes

Jardiance Approved for Type 2 Diabetes

Blocks reabsorption of glucose by kidneys.

FDA Clears First Nasal Testosterone Therapy

FDA Clears First Nasal Testosterone Therapy

The product is self-administered via a nasal applicator.

New Diabetes Drug Approved

New Diabetes Drug Approved

FDA clears albiglutide as an adjunct to diet and exercise for glycemic control in adult type 2 diabetes patients.

Drug Makers Seek New Indication for Prostate Cancer Drug

Drug Makers Seek New Indication for Prostate Cancer Drug

Astellus Pharma and Medivation ask the FDA to approve enzalutamide as a treatment for advanced prostate cancer in chemotherapy-naïve men.

FDA Approves Glucose Monitoring Device for Children

FDA Approves Glucose Monitoring Device for Children

However, device doesn't perform as well in children as in adults, FDA says.

FDA to Review Testosterone Therapy Safety

FDA to Review Testosterone Therapy Safety

Agency pointed to recent studies citing possible heightened heart risk tied to the treatments.

Farxiga Approved for Type 2 Diabetes

Farxiga Approved for Type 2 Diabetes

To be used along with proper diet and exercise.

FDA to Lift Restrictions on Avandia for Diabetes

FDA to Lift Restrictions on Avandia for Diabetes

Not all experts are happy with granting wider access to the troubled medication, however.

FDA Approves Enlarged Prostate Urine Flow Device

FDA Approves Enlarged Prostate Urine Flow Device

UroLift system, a permanent implant, helps relieve blocked urine flow.

FDA Warns Against Fraudulent Diabetes Products

FDA Warns Against Fraudulent Diabetes Products

Products may distract consumers from seeking legitimate medical treatment.

Novel Drug for Metastatic Prostate Cancer Approved

Radium-223, a first-in-class drug, travels directly to the site of bone metastases, where it emits alpha particles that exert an anti-tumor effect.

FDA Announces New Interactive Patient Network

FDA Announces New Interactive Patient Network

Interactive tool designed to educate patients and advocates about processes of drug development.

First-in-Class Diabetes Drug Approved

Canagliflozin blocks reabsorption of glucose in the kidney, increases glucose excretion, and lowers blood glucose levels.