Food and Drug Administration News

Date Posted
Article Title
6/5/2017
Experimental Gene-Targeted Drug Hits Cancer Where It Lives

But the gene flaw is rare, affecting less than 1 percent of typical cancers, researchers say

5/24/2017
New Drug Approved for All Cancers With Genetic Marker

First medication sanctioned for any cancer, regardless of origin

5/24/2017
FDA OKs First Cancer Drug by Genetic Type, Not Organ of Origin

Keytruda is targeted to specific cancers with specific DNA that can arise in multiple sites

5/23/2017
New FDA Head Outlines 'Forceful Steps' Against Opioid Crisis

On the agenda: better-tailored painkiller doses, doctor training and more

5/22/2017
Actemra Approved for Certain Blood Vessel Inflammation

Drug will treat adults with a condition called vasculitis

5/18/2017
Kalydeco Approval Widened for More Types of Cystic Fibrosis

Laboratory evidence used to expand approval

5/17/2017
Diabetes Drug Gets FDA Warning Due to Amputation Risk

Canagliflozin tied to a doubling of amputations of legs, feet, agency says

5/15/2017
New Device Approved for Esophageal Birth Defect

Condition affects 1 in 2,500 babies in U.S.

5/10/2017
Nearly a Third of Drugs Hit by Safety Issues After FDA Approval

Study found serious side effects often arose after medications OK'd for sale

5/8/2017
FDA Approves 1st New Drug for ALS in Decades

Radicava, given intravenously, slows decline in patients with deadly neurological disease

5/5/2017
FDA Warns of Tattoo Dangers

Unsafe practices cause infections, contaminated ink a common culprit, agency says

4/28/2017
Rydapt Approved for Adults With Acute Myeloid Leukemia

A blood cancer that forms in the bone marrow

4/28/2017
Brineura Approved for Rare Genetic Illness Affecting Kids

Batten disease is a neurologic disorder that typically affects young children

4/27/2017
Stivarga Approved for Liver Cancer

First approved treatment for this disease in years

4/25/2017
FDA Warns 14 Companies on Bogus Cancer 'Cures'

Warning letters issued for treatments sold without approval mainly on websites and in social media

4/20/2017
Don't Give Kids Medicines With Codeine, Tramadol: FDA

Agency strengthens warning labels on these medications to address dangers

4/19/2017
FDA Approves Device to Help Curb Cluster Headaches

New technology stimulates a nerve in the neck to help ease the rare but painful syndrome

4/17/2017
New Bowel Disorder Treatments Needed, FDA Says

For now, no cure exists for irritable bowel syndrome

4/13/2017
Could a Clinical Trial Help Your Child?

FDA outlines what to ask before enrollment

4/12/2017
FDA Warns Against Bogus Autism 'Cures'

Unproven therapies won't help and could be harmful, agency says

4/12/2017
1st Drug for Tardive Dyskinesia Approved

Condition characterized by involuntary movement of the jaw, lips and tongue

4/7/2017
FDA Approves Hep C Drugs for Kids 12 and Older

Previously allowed only for adults

4/7/2017
U.S. Blood Supply Safe From Zika Virus, Officials Say

They detail steps being taken to protect people who need transfusions

4/6/2017
FDA Approves 1st Direct-to-Consumer Genetic Risk Tests

They screen for gene variants linked to 10 diseases and conditions

4/6/2017
FDA OKs 1st At-Home Genetic Tests for 10 Disorders

Saliva analysis can indicate higher risk of Parkinson's disease, among others, agency says

4/6/2017
'Right-to-Try' Laws: A Patient's Best Last Chance or False Hope?

Proposal would allow the gravely ill access to experimental therapies that may or may not work

3/29/2017
Ocrevus Approved to Treat Severe Form of Multiple Sclerosis

First drug sanctioned in U.S. for primary progressive MS

3/29/2017
FDA-OK'd Drug Offers Hope to Sickest MS Patients

It's also effective against the most common form of the disease, researchers say

3/28/2017
Dupixent Approved to Treat Eczema

When topical medication doesn't work

3/28/2017
New Eczema Drug Gets FDA's Blessing

Injections may ease itchiness, redness in patients who don't get relief with topical creams, agency says

3/28/2017
Zejula Approved for Certain Female Cancers

Drug may help fight tumors affecting the ovaries, fallopian tubes or abdominal wall

3/23/2017
Bavencio Approved for Rare Skin Cancer

First sanctioned treatment in U.S. for aggressive tumor

3/22/2017
New Parkinson's Drug Xadago Approved

To help prevent 'off' episodes among users of levodopa/carbidopa

3/22/2017
FDA OKs Parkinson's Add-On Drug

Xadago is taken during 'off' periods when symptoms escalate

3/6/2017
Noctiva Approved for Frequent Urination at Night

For adults who awaken to urinate at least twice nightly

3/3/2017
FDA Throws Cold Water on Whole Body Cryotherapy

Exposure to ultra-low temperatures shows no benefits and may be dangerous, agency warns

3/3/2017
Don't Believe Everything You Read on Skin-Care Product Labels

Terms like 'hypoallergenic' and 'fragrance-free' may not mean what you think they do, doctor says

3/2/2017
FDA Approves New Treatment for Dust Mite Allergies

Odactra is a year-round treatment for reactions to the tiny bugs that share your home

3/1/2017
Xermelo Approved for Tumor-Related Diarrhea

Drug will treat a condition called carcinoid syndrome diarrhea

2/16/2017
Siliq Approved for Plaque Psoriasis

Injected drug is for use by patients who've failed other treatments

2/16/2017
FDA Approves Injectable Psoriasis Drug for Tough Cases

But Siliq poses increased risk of suicidal behavior, agency warns

2/13/2017
FDA Issues Warning About Balloon Obesity Treatments

Some devices are over-inflating, and some have been linked to pancreas inflammation, agency says

2/10/2017
Senate Confirms Rep. Tom Price as Health Secretary

Surgeon from Atlanta is outspoken critic of Affordable Care Act

2/9/2017
Emflaza Approved for Duchenne Muscular Dystrophy

First U.S. approval of corticosteroid to treat the disorder

2/6/2017
Newborn Screening Tests Approved

The screens are used to detect four rare metabolic disorders

1/20/2017
Trulance Approved for Chronic Constipation

Drug designed to stimulate upper gastrointestinal tract

1/18/2017
FDA Offers Guidance on Fish Intake for Kids, Pregnant Women

Agency recommends 2-3 servings of 'best choices' weekly

1/3/2017
FDA to Weigh Dangers of Exploding E-Cigarettes

Agency announces 2-day meeting on the safety risks of the lithium batteries that power the devices

12/23/2016
FDA Suggests Limits on Lead in Cosmetics

Agency notes most products already below recommended level

12/22/2016
New MS Drug Shows 'Breakthrough' Promise for Advanced Disease

Specialist hopes ocrelizumab will be available by spring