Cipla has received final approval for its ANDA for darifenacin extended-release tablets, 7.5mg and 15mg, from the US FDA.
Sangamo BioSciences, Inc. Announce that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to SB-FIX, the company's zinc finger nuclease (ZFN)-mediated genome editing product candidate for the treatment of hemophilia B. Sangamo expects to initiate a Phase 1/2 clinical study (SB-FIX-1501) in adult subjects with the disease in 2016.