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FDA approvals hit records in 2017: most ever NMEs, orphan drugs, biosimilar

By Karen Pihl-Carey

Monday, January 8, 2018

If ever a statement was made, it was made in 2017 by the FDA with a record number of approvals that dwarfed last year's numbers in every aspect. The most dramatic change was seen through a doubling of the new molecular entities (NMEs) approved, as well as a 37 percent increase in orphan drug approvals. BioWorld reported on the approval of 46 NMEs, in contrast with 2016's 22 NMEs approved. (See BioWorld Insight, Jan. 2, 2017.)

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