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.

Sep 11, 2014

07:00 ET

Sep 10, 2014

16:39 ET

Sep 10, 2014

10:00 ET

Decision Resources Group Logo.  (PRNewsFoto/Decision Resources Group)

Sep 10, 2014

09:02 ET

Sep 10, 2014

09:00 ET

Sep 10, 2014

08:49 ET

Sep 10, 2014

07:36 ET

Beta O2 Technologies Logo

Sep 09, 2014

17:10 ET

Actavis plc logo. (PRNewsFoto/Actavis plc)

Sep 09, 2014

12:08 ET

Sep 09, 2014

08:30 ET

FC2 Female Condom (PRNewsFoto/The Female Health Company)

Sep 08, 2014

15:07 ET

Sep 08, 2014

14:14 ET

Sep 08, 2014

12:24 ET

Sep 08, 2014

09:10 ET

EPANED, the First and Only FDA-Approved Enalapril Powder for Oral Solution (PRNewsFoto/Silvergate Pharmaceuticals, Inc.)

Sep 08, 2014

09:00 ET

Astute Medical announced FDA clearance of its NeproCheck(R) Test System to aid in acute kidney injury risk assessment. The first-of-a-kind test in the United States checks for the presence of two biomarkers in a urine sample that indicate a patient is at-risk for developing moderate-to-severe kidney injury. (PRNewsFoto/Astute Medical, Inc.)

Sep 08, 2014

07:00 ET

Mylan (PRNewsFoto/Mylan)

Sep 08, 2014

07:00 ET

Sep 06, 2014

08:00 ET

Sep 05, 2014

09:45 ET

Sep 05, 2014

07:45 ET

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