The U.S. FDA approved eight drugs in January 2024, down from 10 approvals the previous January and also down from December’s 21 FDA greenlights. Approvals of new molecular entities also continued to decline, going from six in November to three in December, to one in the first month of 2024.

The U.S. FDA approved 21 drugs in December, bringing the total for the year to 191, a 26% increase to the 151 U.S. approvals in 2022. New molecular entities (NMEs) fell from six in November to three in December, bringing the annual number of NMEs approved to 55.

In November, the U.S. FDA approved a total of 12 drugs, a decrease from 27 the previous month that marked the highest number of approvals since June 2020, as reported by BioWorld. From January to November, FDA approvals reached 167, an increase of 21.9% from 137 drugs approved during the same time period the previous year.

In October, U.S. FDA approvals experienced a significant upswing, reaching a total of 27 for the month, a 92.86% increase from 14 approvals recorded by BioWorld in September. In the initial 10 months of this year, FDA approvals hit 155, an increase of 22.05% from the 127 drugs approved last year, although approvals are down from 2018-2021. Approved new molecular entities are at 29 in 2023, up from 28 in the corresponding period last year but a decline from 2017-2021.

The first three quarters of 2023 delivered a mix of approval news, with an uptick in U.S. FDA clearances over the previous year, but still tracking lower than 2017-2021. Global approvals are on a different trajectory, down year over year.

Approvals from the U.S. FDA are up more than 16% from last year, with 113 drugs approved in the first eight months of 2023. New approvals include two different treatments for relapsed or refractory multiple myeloma, two treatments for ultra-rare diseases and a biosimilar to Biogen Inc.’s Tysabri. In August the FDA greenlighted 13 drugs, approving three NDAs, six BLAs, two supplemental NDAs and two supplemental BLAs.

Drug approvals by the U.S. FDA increased 20.48% compared to the first seven months of 2022, even with July approvals slightly down to 13 from the previous six months’ average of 14.5 per month. Worldwide approvals from January to July are down 13.8% from the same period last year.

U.S. FDA drug approvals increased 19.18% compared to the first six months of last year, with June approvals up to 18 from the previous five months’ average of 14. Worldwide approvals are down 16.8% from the first half of 2022, but up 1.43% compared to the previous seven years’ average.

The first five months of the year showed a slight increase in U.S. FDA approvals, though numbers are down compared to the previous four years. Worldwide approvals are down 16.67% through May, but up 5.42% compared to the previous seven years’ average.

U.S. FDA approvals had a modest increase during the first four months of 2023 compared to last year, but still fall short of the peaks seen in 2019 and 2021.