FDA News

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

Delays in Reporting of Serious Drug Harms to FDA

Delays in Reporting of Serious Drug Harms to FDA

Analysis found roughly 10% of cases were filed after 15-day deadline passed.

Non-Surgical Balloon Device Approved for Obesity

Non-Surgical Balloon Device Approved for Obesity

Inflated in stomach, it may create sense of fullness.

Food Additives Found to Raise Serum Phosphorus

Food Additives Found to Raise Serum Phosphorus

Study implicates dairy products, cereals, and grains containing inorganic phosphate additives.

Short-term NSAID Use May Cause Heart Attack, Stroke, FDA Warns

Short-term NSAID Use May Cause Heart Attack, Stroke, FDA Warns

The risk of heart attack or stroke can occur as early as the first weeks of using an NSAID, the FDA says. The risks may increase with longer use and higher doses. Aspirin is not included in alert.

Entresto Approved for Heart Failure

Entresto Approved for Heart Failure

Entresto helps reduce the rate of cardiovascular death and hospitalization, compared to the drug enalapril.

FDA Seizes Counterfeit ED Medications, More

FDA Seizes Counterfeit ED Medications, More

International effort takes aim at more than 1,050 websites

Food Producers to Remove Trans Fats, Per FDA

Food Producers to Remove Trans Fats, Per FDA

U.S. FDA gives food manufacturers 3 years to remove partially hydrogenated oils from the food supply.

FDA May Approve PCSK9 Inhibitor

FDA May Approve PCSK9 Inhibitor

A PCSK9 Inhibitor could be used by patients who don't respond to statins.

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).