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In response to industry concerns about the FDA’s handling of biosimilar applications, the agency is looking to establish a dedicated biosimilar review unit as part of BsUFA reauthorizations. Read More
Allergan has clinched FDA approval for its hypertension treatment Byvalson, the first fixed-dose combination of a beta blocker and angiotensin II receptor blocker in the U.S. Read More
A second FDA complete response letter to Adamis Pharmaceuticals for its acute anaphylaxis candidate requests an extension of its human factors and reliability studies. Read More