Drug Approval News

Date Posted
Article Title
11/16/2017
11/15/2017
11/14/2017
10/31/2017
10/19/2017
Gene Therapy Approved for B-Cell Lymphoma

The first such treatment for non-Hodgkin form of this cancer

10/9/2017
Remede System Approved for Sleep Apnea

Implantable device stimulates breathing during sleep

10/6/2017
First Test to Detect Zika in Blood Donations Approved

Not designed to diagnose the infection, however

9/29/2017
Verzenio Approved for Advanced Breast Cancer

The most common cancer in the United States

9/28/2017
Glucose Monitoring System Eliminates Need for Finger Pricks

Instead, sensor is implanted below skin in diabetes patients

9/14/2017
9/14/2017
FDA OKs First 'Biosimilar' Drug to Fight Cancer

New biologic could help drive down the cost of care, agency says

9/14/2017
Aliqopa Approved for Follicular Lymphoma

A cancer of the lymph system

9/14/2017
App to Help Treat Substance Abuse Approved

But app is not recommended for opioid dependence

8/30/2017
Pediatric Treatment Approved for 'Kissing Bug' Disease

Benznidazole sanctioned for Chagas infection

8/30/2017
Antibiotic Vabomere Approved

For complicated urinary tract infections

8/30/2017
First Gene Therapy Approved in U.S.

For certain people with blood/bone marrow cancer

8/17/2017
8/15/2017
Is FDA Taking Close Enough Look at Fast-Tracked Drugs?

Study finds many don't get proper follow-up review; second report says some medical devices not getting needed scrutiny

8/4/2017
Mavyret Approved for Hepatitis C

A chronic viral infection of the liver

8/3/2017
New Treatment Approved for Acute Myeloid Leukemia

Vyxeos combines two previously approved drugs

8/2/2017
Imbruvica Approval Expanded to Include Graft Versus Host Disease

A deadly condition that affects some stem cell patients

8/1/2017
Idhifa Approved for Some With Acute Myeloid Leukemia

For adults with specific genetic mutation

7/20/2017
MRI Approved for Young Infants in Intensive Care

Device designed for neonatal brain and head imaging

7/18/2017
Nerlynx Approved to Help Prevent Breast Cancer's Return

Drug is designed to block cancer-fueling enzymes

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

First medication sanctioned for any cancer, regardless of origin

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

5/15/2017
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

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

4/12/2017
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

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

They screen for gene variants linked to 10 diseases and conditions

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

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

3/28/2017
Dupixent Approved to Treat Eczema

When topical medication doesn't work

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

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

For adults who awaken to urinate at least twice nightly

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

2/9/2017
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

12/19/2016
Ovarian Cancer Drug Given Fast-Track Approval

Rubraca's use is specific to women with a mutation of the BRCA gene, FDA said

12/14/2016
Knee Cartilage Product Approved to Repair Defects

Tissue is derived from patient's own knee

11/17/2016
Intrarosa Approved for Post-Menopausal Pain During Sex

Drug contained in a once-daily insert

10/28/2016
Device Approved to Prevent Second Strokes in Certain Heart Patients

It's for people who had prior stroke related to a hole in the heart