The U.S. Food and Drug Administration (FDA) has set a target - TopicsExpress



          

The U.S. Food and Drug Administration (FDA) has set a target review date of July 5, 2015, for the combination therapy of lumacaftor and ivacaftor to treat people with cystic fibrosis ages 12 and older who have two copies of the F508del mutation. The FDA granted a request by Vertex Pharmaceuticals Inc., the developer of the drug, for an accelerated review of the combination therapy application. The potential combination therapy is the first to target the underlying cause of CF in people with two copies of the F508del mutation, the most common form of the disease.
Posted on: Tue, 20 Jan 2015 21:46:24 +0000

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