Page 1 of 4, 192 articles total

Remede System Approved for Sleep Apnea October 09, 2017

Implantable device stimulates breathing during sleep

First Test to Detect Zika in Blood Donations Approved October 06, 2017

Not designed to diagnose the infection, however

Verzenio Approved for Advanced Breast Cancer September 29, 2017

The most common cancer in the United States

Glucose Monitoring System Eliminates Need for Finger Pricks September 28, 2017

Instead, sensor is implanted below skin in diabetes patients

Mvasi Is First Biosimilar Drug Approved for Cancer September 14, 2017

Similar to Avastin

Aliqopa Approved for Follicular Lymphoma September 14, 2017

A cancer of the lymph system

App to Help Treat Substance Abuse Approved September 14, 2017

But app is not recommended for opioid dependence

Pediatric Treatment Approved for 'Kissing Bug' Disease August 30, 2017

Benznidazole sanctioned for Chagas infection

Antibiotic Vabomere Approved August 30, 2017

For complicated urinary tract infections

First Gene Therapy Approved in U.S. August 30, 2017

For certain people with blood/bone marrow cancer

New Treatment Approved for Deadly Blood Cancer August 17, 2017

Acute lymphoblastic leukemia

Mavyret Approved for Hepatitis C August 04, 2017

A chronic viral infection of the liver

New Treatment Approved for Acute Myeloid Leukemia August 03, 2017

Vyxeos combines two previously approved drugs

Imbruvica Approval Expanded to Include Graft Versus Host Disease August 02, 2017

A deadly condition that affects some stem cell patients

Idhifa Approved for Some With Acute Myeloid Leukemia August 01, 2017

For adults with specific genetic mutation

MRI Approved for Young Infants in Intensive Care July 20, 2017

Device designed for neonatal brain and head imaging

Nerlynx Approved to Help Prevent Breast Cancer's Return July 18, 2017

Drug is designed to block cancer-fueling enzymes

New Drug Approved for All Cancers With Genetic Marker May 24, 2017

First medication sanctioned for any cancer, regardless of origin

Actemra Approved for Certain Blood Vessel Inflammation May 22, 2017

Drug will treat adults with a condition called vasculitis

Kalydeco Approval Widened for More Types of Cystic Fibrosis May 18, 2017

Laboratory evidence used to expand approval

New Device Approved for Esophageal Birth Defect May 15, 2017

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

Rydapt Approved for Adults With Acute Myeloid Leukemia April 28, 2017

A blood cancer that forms in the bone marrow

Brineura Approved for Rare Genetic Illness Affecting Kids April 28, 2017

Batten disease is a neurologic disorder that typically affects young children

Stivarga Approved for Liver Cancer April 27, 2017

First approved treatment for this disease in years

1st Drug for Tardive Dyskinesia Approved April 12, 2017

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

FDA Approves Hep C Drugs for Kids 12 and Older April 07, 2017

Previously allowed only for adults

FDA Approves 1st Direct-to-Consumer Genetic Risk Tests April 06, 2017

They screen for gene variants linked to 10 diseases and conditions

Ocrevus Approved to Treat Severe Form of Multiple Sclerosis March 29, 2017

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

Dupixent Approved to Treat Eczema March 28, 2017

When topical medication doesn't work

Zejula Approved for Certain Female Cancers March 28, 2017

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

Bavencio Approved for Rare Skin Cancer March 23, 2017

First sanctioned treatment in U.S. for aggressive tumor

New Parkinson's Drug Xadago Approved March 22, 2017

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

Noctiva Approved for Frequent Urination at Night March 06, 2017

For adults who awaken to urinate at least twice nightly

Xermelo Approved for Tumor-Related Diarrhea March 01, 2017

Drug will treat a condition called carcinoid syndrome diarrhea

Siliq Approved for Plaque Psoriasis February 16, 2017

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

Emflaza Approved for Duchenne Muscular Dystrophy February 09, 2017

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

Newborn Screening Tests Approved February 06, 2017

The screens are used to detect four rare metabolic disorders

Trulance Approved for Chronic Constipation January 20, 2017

Drug designed to stimulate upper gastrointestinal tract

Ovarian Cancer Drug Given Fast-Track Approval December 19, 2016

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

Knee Cartilage Product Approved to Repair Defects December 14, 2016

Tissue is derived from patient's own knee

Intrarosa Approved for Post-Menopausal Pain During Sex November 17, 2016

Drug contained in a once-daily insert

Device Approved to Prevent Second Strokes in Certain Heart Patients October 28, 2016

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

New Treatment Approved for Soft-Tissue Cancers October 19, 2016

Malignancies that develop in muscles, fat, tendons and blood vessels

'Artificial Pancreas' Approved for Type 1 Diabetes September 28, 2016

An automated delivery device for insulin

Amjevita OK'd to Treat Inflammatory Diseases September 26, 2016

For several arthritic and gastrointestinal conditions

First Drug Approved for Duchenne Muscular Dystrophy September 19, 2016

Exondys 51 sanctioned for certain gene mutation

Balloon Device Approved for Eustachian Tube Problems September 16, 2016

Designed to relieve pain or clogged sensations in ear

Laser Device Approved for Nearsightedness September 14, 2016

Surgery permanently reshapes eye's cornea

Clot Retrieval Device Approval Expanded September 06, 2016

Instruments help avoid disability among stroke patients

Head Injury Screening Tests Approved August 22, 2016

Assess brain function after possible concussions

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