Drug Topics January 16, 2023
New approvals include gene therapies, first-in-class drugs, treatments for rare diseases, and cancer, as well as biosimilars.
The FDA’s two main drug review centers — the Center for Drug Evaluation (CDER) and Research and the Center for Biologics Evaluation and Research (CBER) — in 2022 approved a total of 49 new therapies. Of these, 37 had been approved by CDER and the remaining, including several gene therapies, were approved through CBER.
The 2022 approvals through Center for Drug Evaluation target many different disease areas, including COVID-19, HIV, smallpox, influenza, and H. pylori infection. Also approved were therapies for two severe and progressive neurological conditions, amyotrophic lateral sclerosis and spinal muscular atrophy.
“2022 marked the third consecutive year that COVID-19 has...
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