FDA News

FDA Approves Device to Treat Obesity

FDA Approves Device to Treat Obesity

The U.S. Food and Drug Administration has approved the first weight loss treatment device, the Maestro Rechargeable System by EnteroMedics of St. Paul, Minnesota.

FDA Approves Combo Zerbaxa for UTI

FDA Approves Combo Zerbaxa for UTI

Combo Zerbaxa is sanctioned for complicated intra-abdominal and urinary tract infections

FDA Approves System to Reduce Pathogens in Donated Blood Plasma

FDA Approves System to Reduce Pathogens in Donated Blood Plasma

Targeted pathogens include AIDS-causing HIV, hepatitis B and C, and the West Nile virus

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.