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Last year was a productive one for the FDA’s CDER, which approved 45 novel drugs — an increase from its 2006 to 2014 average of 28, according to the agency’s 2015 Novel New Drugs Summary released Monday. Read More
In anticipation of proposed guidance on biosimilar interchangeability, AbbVie is requesting that the FDA hold a hearing to ensure the agency considers all viewpoints. Read More
The FDA is postponing its decision on BioMarin’s investigational drug drisapersen for Duchenne muscular dystrophy, saying the review is still under way. Read More