Pharmaceutical industry is very challenging, and involves huge investments, strong regulations, and low output in terms of new drugs.

FDA has set a new record for new drug approvals in 2018 by approving 59 novel drugs and biologics, plus two recombinant therapies

taking the total count to 61. Drugs approved in 2018 are listed in table 1. Number of new molecular entities (NMEs) and biologics approved

by FDA exceeded its earlier record of 53 approvals in 1996. Number of new products approved by FDA in 2018 is nearly double its

10-year average of 33 approvals per year.