FDA News

Corlanor Approved for Chronic Heart Failure

Corlanor Approved for Chronic Heart Failure

Corlanor works by decreasing heart rate; it's the first approved product in this drug class.

Feraheme Can Cause Serious Allergic Reactions

Feraheme Can Cause Serious Allergic Reactions

The Food and Drug Administration (FDA) has strengthened an existing warning regarding serious and potentially fatal allergic reactions that can occur with Feraheme (ferumoxytol; AMAG Pharmaceuticals).

FDA Authorizes Device for Dialysis-Related Amyloidosis

FDA Authorizes Device for Dialysis-Related Amyloidosis

Lixelle Beta 2-microglobulin Apheresis Column authorized for use in DRA

Testosterone Nasal Gel Effective for Hypogonadism, Low Side Effects

Testosterone Nasal Gel Effective for Hypogonadism, Low Side Effects

Three doses of testosterone nasal gel may help normalize testosterone levels in men with hypogonadism.

Never Share Diabetes Pens, FDA Warns

Never Share Diabetes Pens, FDA Warns

Even if the needle is changed, diabetes pens may harbor traces of blood on other parts.

FDA Adds CVD Warning to Testosterone Replacement

FDA Adds CVD Warning to Testosterone Replacement

Prescription testosterone product labels must now include warnings about the possible increased risk of heart attacks and strokes, says FDA.

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.