So far this year, 27 novel drugs have been approved compared to 41 during the same period last year. 2018 holds the record for the maximum number of new drug approvals – with 59 drugs compared to 46 in 2017. Novel drugs are new molecular entities (NMEs) having chemical structures that have never been approved before.Now, let's take a look at the companies that await a ruling from the FDA in October 2019.