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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

Adlyxin Approved for Type 2 Diabetes July 28, 2016

Hormone helps control blood sugar

Xiidra Eyedrops Approved to Treat Dry Eye July 12, 2016

Symptoms more likely as people age

Ultrasound Device Approved to Treat Essential Tremor July 11, 2016

Uses MRI to help destroy brain tissue that's behind involuntary movement

Acne Treatment Differin Gel Approved for OTC Use July 11, 2016

Among people 12 and older

1st HPV Test for Use With Preservative Fluid July 08, 2016

Human papillomavirus responsible for 70 percent of cervical cancers

FDA Approves First Fully Dissolvable Stent July 05, 2016

Device is absorbed by the body after about three years

New Test Help Detect Drug-Resistant Bacteria June 30, 2016

Uses specimens taken directly from patients

Epclusa Approved for Chronic Hepatitis C June 28, 2016

Combination drug treats six major forms of HCV

Ocaliva Approved for Rare Liver Disease May 31, 2016

Primary biliary cholangitis causes inflamed bile ducts

Nuplazid Approved for Parkinson's Hallucinations May 02, 2016

Half of people with Parkinson's may have them

Makers of Corn Masa Flour Can Add Folic Acid April 14, 2016

Vitamin helps prevent birth defects

Venclexta Approved for Specific Genetic Blood Cancer April 11, 2016

A form of chronic lymphocytic leukemia

First Wire-Free Pacemaker Approved April 08, 2016

Treats irregular heartbeat without wired leads

Inflectra Approved as 'Biosimilar' to Remicade April 06, 2016

For adults with Crohn's, rheumatoid arthritis or psoriasis

First Treatment Approved for Disease Linked to Stem Cell Transplant March 30, 2016

Liver condition is rare, but deadly

Cinqair Approved for Severe Asthma March 23, 2016

Helps reduce certain white blood cells that contribute to the disease

Inhalation Anthrax Treatment Approved March 21, 2016

A potential bioterror threat

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