FDA Approval The latest news regarding FDA applications, processes, and approval. This section contains releases regarding the Food and Drug Administration’s consideration of new products, drugs, therapies and treatments. Find announcements covering every stage of the FDA application process, from filing to eventual approval, including appeals, resubmissions, and safety alerts.

Aug 20, 2014

15:33 ET

Aug 20, 2014

09:37 ET

Aug 19, 2014

19:30 ET

Aug 19, 2014

19:30 ET

Aug 19, 2014

19:30 ET

Aug 19, 2014

11:42 ET

Mylan (PRNewsFoto/Mylan)

Aug 19, 2014

11:36 ET

Aug 19, 2014

09:00 ET

ViaCyte logo.  (PRNewsFoto/ViaCyte, Inc.)

Aug 19, 2014

08:15 ET

Aug 19, 2014

01:55 ET

Gamida Cell Logo

Aug 18, 2014

17:32 ET

Eli Lilly and Company logo. (PRNewsFoto, Eli Lilly and Company)

Aug 15, 2014

14:30 ET

Aug 14, 2014

16:45 ET

Aug 14, 2014

16:35 ET

Aug 14, 2014

09:00 ET

Syneron Medical Ltd logo

Aug 13, 2014

13:08 ET

TMJ NextGeneration(TM) is a first-of-its-kind, FDA cleared medical device that is a safe and effective aid in reducing Temporomandibular Joint Disorder (TMJD) pain. The device consists of two custom-made, hollow ear canal inserts that allow full passage of sound and are practically invisible from the outside. (PRNewsFoto/TMJ Health, LLC)

Aug 13, 2014

10:07 ET

Aug 12, 2014

19:01 ET

FDA approves first noninvasive DNA screening test for colorectal cancer (PRNewsFoto/Exact Sciences Corp.)

Aug 12, 2014

09:00 ET

Aug 12, 2014

08:45 ET

OS2966 is an investigational therapy developed by W. Shawn Carbonell, MD, PhD, Founder and CEO of OncoSynergy (pictured), for the potential treatment of aggressive solid cancers including glioblastoma. (Photo credit: Jackson Solway) (PRNewsFoto/OncoSynergy, Inc.)

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