21 January 2019 - It's not hyperbolic to say that 2018 was a sensational year for FDA approvals of new drugs and biologics. And this occurred on the heels of a highly successful 2017, with the largest number of approvals in more than two decades. 

Once again in 2018, orphan and cancer drug approvals led the pack. Of the 59 new drugs approved in 2018 by the Center for Drug Evaluation and Research, 34 were drugs targeting rare diseases, 19 were first-in-class agents, and seven were biosimilars. Also, 43 (73%) went through the priority review process, 24 (41%) were fast-tracked, and 14 (24%) were designated as breakthrough therapies.

In 2018, there were many notable firsts, including tagraxofusp (Elzonris) indicated for a rare and aggressive form of blood cancer, the first oral treatment for Fabry disease migalastat (Galafold), and the first preventive therapeutic for migraine erenumab (Aimovig).

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