For months, it had been clear that 2018 would be a banner year for pharmaceutical innovation. The question was, by how much would it shatter the previous (1996) record of 50 approvals (excluding diagnostics and imaging agents)? We now know. It exceeded it by over 20 percent. Last year, U.S. regulators approved a total of 61 drugs – 59 by FDA’s Center for Drug Evaluation and Research (CDER), plus two recombinant therapies (Andexxa and Jivi) by its Center for Biologics Evaluation and Research (CBER).