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Exondys 51 (eteplirsen) injection has been approved by the U.S. Food and Drug Administration for certain patients with Duchenne muscular dystrophy. It is the first drug to gain FDA approval for the condition.

FDA Approves First Drug for Duchenne Muscular Dystrophy

Exondys 51 sanctioned for patients with mutation of the dystrophin gene amenable to exon 51 skipping
A device that uses a small balloon to treat Eustachian tube dysfunction has been approved by the U.S. Food and Drug Administration.

FDA Approves Balloon Device for Eustachian Tube Dysfunction

Designed to relieve pressure, pain, or clogged or muffled sensations occuring in the ear
A new biological drug to treat rheumatoid arthritis and other inflammatory diseases has been approved by the U.S. Food and Drug Administration.

FDA Approves Biosimilar Drug Erelzi for Rheumatoid Arthritis

Erelzi is a biosimilar for Enbrel; treats RA and other inflammatory diseases
The first generic version of the flu medication Tamiflu has been approved by the U.S. Food and Drug Administration.

FDA Approves First Generic Version of Tamiflu

Oseltamivir phosphate does not take the place of receiving a flu vaccination
Adlyxin (lixisenatide)

FDA Approves Adlyxin for Type 2 Diabetes Mellitus

Once-daily injection to improve glycemic control, along with diet and exercise
Xiidra (lifitegrast) eye drops have been approved by the U.S. Food and Drug Administration to treat symptoms of dry eye disease.

FDA Approves Xiidra Eye Drops to Treat Dry Eye Disease

First approved lymphocyte function-associated antigen agonist
The once-daily acne treatment Differin Gel 0.1% (adapalene) has been approved for over-the-counter use among patients 12 and older

FDA Approves Differin Gel for Over-the-Counter Use

First OTC retinoid available for acne treatment among patients 12 and older
The ExAblate Neuro device has been approved by the U.S. Food and Drug Administration to deliver focused ultrasound to destroy tissue in a tiny area of the brain that is thought to be involved in essential tremor.

FDA Approves Ultrasound Device to Treat Essential Tremor

Focused ultrasound device to treat essential tremor in patients who have not responded to medication
The first coronary stent to be gradually absorbed by the body has been approved by the U.S. Food and Drug Administration.

FDA Approves First Absorbable Coronary Stent

Device is absorbed by the body after about three years
The Xpert Carba-R Assay diagnostic

FDA Approves New Test to Help Detect Drug-Resistant Bacteria

Uses specimens taken directly from patients; specifically looks for resistance to carbapenems