Food and Drug Administration News

Date Posted
Article Title
3/20/2014
Impavido Approved to Treat Tropical Parasitic Disease

Americans typically contract it while traveling

3/13/2014
FDA Panel Recommends HPV Test As Replacement for Pap Smear

Experts voted 13-0 that Roche's test was safe and effective as first step in cervical cancer screening

3/12/2014
Experimental Drug May Boost Leukemia Survival, Without Chemo

Idelalisib is being fast-tracked for FDA approval for use in patients with chronic lymphocytic leukemia

3/12/2014
First Device Approved to Prevent Migraines

Headband-like unit stimulates nerve associated with painful headaches

3/11/2014
FDA Approves First Device to Prevent Migraines

Wearable headband uses electrodes to stimulate nerve tied to the headaches

3/7/2014
Pfizer Recalls Some Antidepressants After Drug Mixup

Action taken after pharmacist found a heart drug among Effexor/Venlafaxine, FDA says

3/4/2014
Some U.S. Clinical Trials May Fall Into Federal Regulation 'Gap'

For these studies, patient safety might be covered by states, other entities, experts say

3/2/2014
Eye-Catching Labels Urged for Fast-Tracked Antibiotics

Letter to Congress from medical groups focuses on 'superbug' threat

2/27/2014
Study Questions FDA Warning Against CT Scans for Those With Heart Devices

It found no harm to patients with devices such as pacemakers, defibrillators, but agency still concerned

2/27/2014
FDA's New Food Labels Would Focus on Calories, Sugar Content

Another goal: give consumers a better understanding of realistic serving sizes

2/26/2014
Study Sees No Evidence Linking Diabetes Drugs With Pancreatic Cancer

But FDA assessment calls for further look at injectable type-2 treatments

2/26/2014
Groups Push FDA to Revoke Approval of Highly Potent Painkiller

One dose of Zohydro could kill a child, say coalition of consumer advocates, addiction specialists

2/25/2014
FDA Explores '3-Person' Embryo Fertilization

Meant to prevent genetic diseases in children, the procedure raises ethical issues

2/25/2014
Myalept Approved for Rare Fat Tissue Disorder

Drug is meant for people with deficiency of the hormone leptin

2/24/2014
FDA To Step Up Oversight of Indian Drug Makers

More inspectors planned as India emerges as growing source of pharmaceuticals

2/19/2014
Northera Approved For Rare Blood Pressure Condition

Neurogenic orthostatic hypotension is most often tied to Parkinson's disease

2/17/2014
2/12/2014
Imbruvica Approval Expanded to Include Chronic Leukemia

Drug inhibits enzyme that spurs cancer growth

2/11/2014
FDA Panel Sees No Heart-Safety Advantage With Naproxen

Some studies had suggested naproxen (Aleve) might pose less of a threat than other painkillers

2/11/2014
FDA to Investigate Diabetes Drug Saxagliptin for Possible Heart Failure Risk

Marketed as Onglyza and Kombiglyze XR, drug appears to have no effect on heart attack or stroke risk

2/10/2014
2/10/2014
FDA Advisers Revisit Heart Risks Posed by Painkillers

Studies suggest naproxen (Aleve) may pose less of a threat

2/5/2014
There's Still Time to Get a Flu Shot

Younger adults seem at risk this year, FDA says

2/4/2014
Blood Sugar Monitoring System Approved for Children

However, device didn't perform as well in kids as in adults, FDA says

2/3/2014
FDA Will Review Safety of Testosterone Therapy

Agency pointed to recent studies citing possible heightened heart risk tied to the treatments

1/31/2014
Hetlioz Approved for Sleep Disorder in Blind People

Condition stems from inability to govern sleep from light-dark cycle

1/24/2014
FDA Wants to Update Food Labels

Goal is a better informed public

1/21/2014
FDA Approval Process Comes Under Scrutiny in Studies

Drugs face inconsistent standards, heart device upgrades may not undergo clinical trials, researchers say

1/17/2014
New Test Helps Diagnose Intellectual Disability in Children

Scan tracks entire genome from a blood sample

1/17/2014
Americans Eating Better, Cutting Calories: USDA

Report also shows consumers using nutrition labels more, dining out less

1/17/2014
Truck Drivers Top List of Overweight Workers

Survey of Washington state residents also found salespeople, office workers prone to weight gain

1/16/2014
FDA Warns of Fires From Wart Removers

Don't use flammable products near candles, hair appliances, agency says

1/15/2014
FDA Warns Against Prescription Drugs With High Levels of Acetaminophen

Officials say action taken because of reports of severe liver damage from accidental overdoses

1/14/2014
Merck Recalls Cholesterol Drug Liptruzet

Packaging problem could allow air, moisture to affect drug's effectiveness, company says

1/10/2014
FDA OKs 2-Drug Combo Treatment for Advanced Melanoma

In trial, Mekinist and Tafinlar together seemed to perform better than Tafinlar alone, agency says

1/10/2014
Mekinist Plus Tafinlar Approved for Late-Stage Melanoma

The most deadly form of skin cancer

1/10/2014
Sealant Gel Approved for Eye Surgery

An additional option after cataract operation

1/9/2014
Dietary Supplements Can't Treat or Cure Concussions: FDA

Agency tells consumers to ignore manufacturer claims and 'walk away' from these products

1/9/2014
FDA Warns Against Misuse of Laxatives

Ignoring dosing instructions, cautions can lead to serious side effects with some of these products

1/8/2014
Farxiga Approved for Type 2 Diabetes

Along with diet and exercise

1/8/2014
Liquid Tamiflu for Kids in Short Supply

Shortage should be resolved in week; Tamiflu capsules and flu shots widely available, U.S. officials say

1/7/2014
Kids' Suicide Risk Similar for All Newer Antidepressants: Study

Children had roughly the same risk for suicidal thoughts and behaviors, regardless of drug they were taking

1/3/2014
E-Cigarettes: Separating Fiction From Fact

Health experts say more research needed into the devices' safety and effectiveness as a quit-smoking tool

1/2/2014
Novel Osteoporosis Drug Could Change Treatment: Study

Early results indicate romosozumab can rebuild bone

12/27/2013
Portable Bed Rails Can Pose Safety Hazard, FDA Says

Agency explains how to reduce potential for falling or being trapped

12/27/2013
FDA Warns Consumers Against Body-Building Supplement

Agency says Mass Destruction is linked to case of liver failure

12/23/2013
Tretten Approved for Genetic Clotting Disorder

Rare condition could be life threatening

12/20/2013
FDA Introduces New Food Defense Rule

Goal is to protect U.S. food supply from potential terrorist acts

12/19/2013
Stent to Treat Pancreatic Cysts Approved

For infected cysts that won't drain on their own

12/19/2013
Survey Finds Support for Banning E-Cigarette Use by Kids

86 percent of adults polled said the nicotine-delivery devices should not be sold to minors