FDA approved a record number of drugs in 2018 – APhA submits compounding comments to FDA. – (866) 348-2889.
FDA drug approvals hit an all-time high in 2018, with 59 new molecular entities securing the agency’s permission to head to market. Small molecules comprised 64% of therapies approved in 2018, while antibodies represented 20% of approvals. With 15% of new drugs falling outside of those two main modalities, the list also reflects the increasingly diverse approaches researchers are using to take down diseases—particularly rare, genetic diseases. The 2018 class also brought treatments for long-underserved diseases, including a new class of drug for migraine prevention, the first new drug for endometriosis in over a decade, and the first marijuana-extracted treatment for a rare form of epilepsy.