To date, the agency has approved 27 novel new medicines this year, including biologics, matching the number of new drug approvals for all of last year.
"However, determining an approval rate is tricky," WSJ noted. "That’s because the applications that the FDA receives each year almost never equate with the actual drugs that are approved in the same year." "[T]here were nine applications submitted through March, according to agency data. And last year, when 27 novel new drugs were approved, the agency received 36 applications [in that time frame]."