Regulatory Trends in the US Pharma/Biotech Industry

Key Findings

NME Trends Show a Significant Increase in Regulatory Filings and Approvals

Increase in Orphan Drug Approvals

Increase in First-in-class Designation

Most Approved NMEs Evaluated as an Expedited Review

High Number of First Cycle Approval Continues

Oral Therapies Continue Dominating the Pharma/Biotech Industry

NMEs Approved in 2014

NMEs Approved in 2014 (continued)

NMEs Approved in 2014 (continued)

NMEs Approved in 2014 (continued)

NMEs Approved in 2014 (continued)

NMEs Approved in 2014 (continued)

NMEs Approved in 2014 (continued)

NMEs Approved in 2014 (continued)

NMEs Approved in 2014 (continued)

NMEs Approved in 2014 (continued)

NMEs Approved in 2014 (continued)

NMEs Approved in 2014 (continued)

NMEs Approved in 2014 (continued)

NMEs Approved in 2014 (continued)

NMEs Approved in 2014 (continued)

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