The FDA approved 59 novel drugs in 2018 — crushing all previous records, according to a report from pharma news website PM Live.
In 2018, the industry saw a surge in new approvals in chemical entities and new biologic drugs, driven by novel science and the FDA's new guidance to accelerate the approval process.
More than half of the new approvals were for rare diseases.
In 2017, the FDA approved 46 drugs, which matched the record in 2015.