Food and Drug Administration News

Date Posted
Article Title
4/11/2011
1st U.S. Test to Diagnose Dengue Fever Approved

Illness more common in Latin America, Caribbean and Asia

4/8/2011
FDA OKs Rapid Test to Spot Dangerous Intestinal Infection

C. difficile is commonly acquired in hospitals

4/7/2011
Horizant Approved to Treat Restless Legs Syndrome

Possible side effects include drowsiness and dizziness

4/7/2011
Vandetanib Approved for a Rare Thyroid Cancer

Designed to extend survival in patients with late-stage disease

4/4/2011
Nerve Stimulation Device Approved to Restore Bowel Control

For people with chronic fecal incontinence

4/1/2011
FDA Panel Delays Action on Dyes Used in Foods

It calls for more research, but many parents and scientists fear link to ADHD

3/30/2011
FDA Panel Examines Possible Links Between Food Dyes, ADHD

It's the first time the agency has ever seriously looked at the issue, experts say

3/29/2011
Just-Approved Defibrillators Limit Unnecessary Shocks

Medtronic devices said to recognize irregular heartbeat that's life-threatening

3/25/2011
Drug Approved for Late-Stage Melanoma

Yervoy fights deadly form of skin cancer, agency says

3/24/2011
U.S. Shingles Vaccine Approval Expanded

To include people in their 50s

3/15/2011
Gadavist Approved to Enhance Nervous System Imaging

A contrast agent for certain MRIs

3/11/2011
Device Approved to Continue Blood Flow During Brain Surgery

Among patients at greater risk of stroke

3/10/2011
Benlysta Approved for Lupus

Last-approved lupus drug sanctioned 56 years ago

3/10/2011
Home Genetic Tests May Need Doctor's Involvement: Report

FDA will probably make determinations on a case-by-case basis, official says

3/10/2011
FDA Approves 1st New Lupus Drug in More Than 50 Years

Patients receiving Benlysta did far better than those receiving placebo, researchers found

3/8/2011
FDA Weighs Pros, Cons of Home Genetic Testing

Agency advisers, test manufacturers convene for two-day hearing

3/2/2011
FDA Bans Unapproved Prescription Cough, Cold and Allergy Meds

Some 500 untested drugs will be removed from the market, agency said

3/1/2011
Heart Devices Not Tested Enough in Women: Study

FDA disregards its own mandate for data on women in clinical trials, researchers contend

3/1/2011
Roflumilast Approved for Form of COPD

Drug aimed at treating lung disease characterized by chronic bronchitis

2/28/2011
Edarbi Approved for High Blood Pressure

But shouldn't be taken by pregnant women

2/23/2011
Fast Response Crucial in Outbreaks of Food-Borne Illness: Study

Scientists say swift action can contain the problem, limit number of infections

2/18/2011
2/17/2011
People Who Weigh Less Now Qualify for Gastric Device

Under new approval, Lap-Band system can now be used by less obese

2/16/2011
Parents Still Giving Cough, Cold Meds to Kids Under 2: Poll

Many caregivers, doctors not heeding FDA warning about dangers of over-the-counter drugs

2/14/2011
Report Blames Speedy FDA Clearance for Medical Device Recalls

But agency notes steps have been taken to strengthen approval system

2/14/2011
Energy Drinks May Hurt Kids: Study

Children with existing health or emotional issues most at risk, researchers say

2/11/2011
Test Approved to Monitor Levels of Kidney Rejection Drug

Too much of the drug in blood may be toxic

2/11/2011
First 3-D Mammography Test Cleared

To help screen for breast cancer

2/8/2011
MRI-Friendly Pacemaker Approved

System designed to work with magnetic resonance imaging devices

2/4/2011
'Black Box' Drug Warning Labels Applied Inconsistently: Study

Uniform standards urged to help prevent consumer confusion about medication risks

2/4/2011
Drug Approved to Help Prevent Preterm Birth

Makena for women at risk of delivering early

2/1/2011
More Evidence Cancer Drug Avastin May Cause Harm

Increased risk of death seen in review of 16 trials

1/31/2011
New Oral Drugs Hailed for Treating MS

Next step, experts say, is to find ways to repair damage done by the disease

1/26/2011
FDA Panel Recommends Tougher Standards for External Defibrillators

Recalls, failure to fix problems spurred agency to ask for more oversight

1/25/2011
1/24/2011
Viibryd Approved for Major Depressive Disorder

When symptoms of depression interfere with daily life

1/18/2011
Natroba Approved for Head Lice

For people 4 years and older

1/18/2011
Stents Show Promise in Treating Brain Blockages

For certain stroke patients, experimental stenting opened clogged artery, study finds

1/13/2011
FDA Lowers Amount of Acetaminophen Allowed in Prescription Painkillers

Agency officials say action taken because of reports of severe liver damage

1/10/2011
Abstral Approved for Adults With Cancer Pain

Opioid drug to be distributed via program to deter misuse

1/5/2011
FDA Launches Review of Tobacco Products

New, changed items can be no more harmful than products already on market

1/4/2011
Obama to Sign Bill to Improve U.S. Food Safety

Measure gives FDA new powers to protect public

1/2/2011
U.S. Health Care Reform Tops Health News for 2010

Food safety reform and the flu epidemic that fizzled also made headlines this year

12/22/2010
U.S. Food-Safety Laws Overhauled

Bill awaiting Obama's signature would give FDA new powers to protect public

12/21/2010
Device Approved for Dangerous Vessel Bulge

Endurant stent graft treats aneurysm in abdominal aorta

12/17/2010
12/16/2010
FDA Advises Against Avastin as Treatment for Breast Cancer

But patients won't be affected for now, FDA says

12/16/2010
U.S. Spending Millions to See if Herbs Truly Work

Research aims to remove the mystery around popular dietary supplements

12/16/2010
FDA Panel Calls for Safety Review of Mercury in Dental Fillings

Committee notes new research that might point to potential problems

12/15/2010
'Tainted' Supplement Makers May Face Prosecution: FDA

Move follows reports of injuries or death from synthetic steroids, other products