FDA News

FDA's 'Breakthrough' Drug Designation Misunderstood

FDA's 'Breakthrough' Drug Designation Misunderstood

Many believe meds supported by stronger evidence than the law requires to achieve designation.

Metformin Use Expanded to Some Patients With Reduced Kidney Function

Metformin Use Expanded to Some Patients With Reduced Kidney Function

The diabetes drug was contraindicated due to the risk of lactic acidosis.

2 Diabetes Medications Carry Risks for Kidney Patients, FDA Says

2 Diabetes Medications Carry Risks for Kidney Patients, FDA Says

Drugs containing saxagliptin or alogliptin may be linked to heart failure risk.

FDA Adds Boxed Warning to Opioid Pain Medications

FDA Adds Boxed Warning to Opioid Pain Medications

New labeling rules require immediate-release opioids to carry warnings for the serious risk for misuse.

FDA Tightens Rules for Surgical Mesh in Pelvic Prolapse Repair

FDA Tightens Rules for Surgical Mesh in Pelvic Prolapse Repair

Agency aims to improve treatment of pelvic organ prolapse.

FDA Allows Blood Donations by Men Who Have Sex With Men

FDA Allows Blood Donations by Men Who Have Sex With Men

National blood surveillance system will help agency ensure safety of the blood supply.

Uptravi Approved for Pulmonary Arterial Hypertension

Uptravi Approved for Pulmonary Arterial Hypertension

Drug found to limit worsening of the disease and reduce the need for hospitalization.

FDA Approves New Drug for Advanced Kidney Cancer

FDA Approves New Drug for Advanced Kidney Cancer

Nivolumab is cleared for treating patients with metastatic RCC whose disease advanced despite prior treatment with anti-angiogenic therapy.

FDA Approves Hyperkalemia Drug

FDA Approves Hyperkalemia Drug

Patiromer for oral suspension lowers potassium levels in hyperkalemic patients with chronic kidney disease.

FDA Approves Two New Diabetes Insulins

FDA Approves Two New Diabetes Insulins

Tresiba and Ryzodeg approved for use in adults with type 1 and 2 diabetes mellitus.

Varubi Approved for Chemo-Induced Nausea, Vomiting

Varubi Approved for Chemo-Induced Nausea, Vomiting

The FDA approved Varubi for prevention of the delayed phase of nausea and vomiting caused by chemotherapy.

Joint Pain Linked to DPP-4 Inhibitor Use by Type 2 Diabetics

Joint Pain Linked to DPP-4 Inhibitor Use by Type 2 Diabetics

FDA advises diabetes patients taking DPP-inhibitors who experience severe joint pain to contact their doctors.

FDA Approves Repatha for Familial High Cholesterol

FDA Approves Repatha for Familial High Cholesterol

Approved for patients unable to get LDL cholesterol under control with current treatment options.

Addyi Approved to Treat Women with Low Sexual Desire

Addyi Approved to Treat Women with Low Sexual Desire

Addyi to treat generalized hypoactive sexual desire disorder among premenopausal women.

Why Heart Safety of Testosterone in Older Men Remains a Concern

Why Heart Safety of Testosterone in Older Men Remains a Concern

Most men prescribed testosterone have age-related hypogonadism, for which treatment is not FDA-approved