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Novel FDA drug approvals fell to 55 in 2024 from 71 in 2023, in Sleuth’s count
The FDA approved fewer novel drugs in 2024 than in 2023, but the drop says more about an unusually strong 2023 than a weak 2024. Sleuth’s count as of December 27, 2024 puts the year at 55 novel approvals, 47 from the Center for Drug Evaluation and Research (CDER) and eight from the Center for Biologics Evaluation and Research (CBER), about 22% fewer than 2023’s 71 (55 from CDER and 16 from CBER). CDER’s 2023 total was the second highest in 30 years, behind 59 in 2018, while its 47 in 2024 matched the 10-year average of 46.
CDER’s 2024 output matched a structurally higher baseline
By Sleuth’s count, CDER’s 10-year rolling average of 46 novel approvals a year is the highest in more than 20 years, up from a low of about 25 in 2010. FDA’s final CDER list for 2024 has 50 novel approvals, because it also counts three imaging and diagnostic agents that Sleuth’s list excludes: Lumisight, Flyrcado and Iomervu. On that basis, 2024 finished at 50 against 55 in 2023.
A year that looks soft against 2023 is still well above the approval pace of the 2000s, so 2024 reads as a return to trend rather than a slowdown.
Small molecules and cancer drugs led CDER’s 2024 approvals
Of the 47 CDER approvals on Sleuth’s list, 29 were small molecules, 13 were antibodies, four were other biologics and one, Ionis’ Tryngolza (olezarsen) for familial chylomicronemia syndrome, was an antisense oligonucleotide. Cancer drugs accounted for 14, including three in non-small cell lung cancer (NSCLC): Johnson & Johnson’s Lazcluze, Merus’ Bizengri and Ensacove. Outside oncology, the list includes Madrigal’s Rezdiffra for NASH, Merck’s Winrevair for pulmonary arterial hypertension, Lilly’s Kisunla for Alzheimer’s disease, Bristol Myers Squibb’s Cobenfy for schizophrenia, BridgeBio’s Attruby for ATTR-CM and Vertex’s Alyftrek for cystic fibrosis.
CBER’s eight approvals on Sleuth’s list split into three cell therapies, three gene therapies and two vaccines. The cell therapies were Iovance’s Amtagvi for melanoma, Adaptimmune’s Tecelra for synovial sarcoma and Autolus’ Aucatzyl for relapsed or refractory B-cell acute lymphoblastic leukemia. The gene therapies were Kyowa Kirin’s Lenmeldy for metachromatic leukodystrophy, Pfizer’s Beqvez for hemophilia B and PTC’s Kebilidi for AADC deficiency, and the vaccines were Moderna’s Mresvia for RSV and Merck’s Capvaxive for pneumococcal disease.
Small molecules still carried most of 2024’s approval volume, while cell and gene therapies accounted for six of the 55 approvals.
Accelerated approvals arrived with confirmatory trials already running
In Sleuth’s review, 2024 had one of the highest counts of accelerated approvals, but most of those drugs already had active Phase 3 studies when they were approved. That reflects the Food and Drug Omnibus Reform Act of 2022 (FDORA), which lets the FDA require confirmatory studies to be underway before approval, a response to confirmatory trials that had dragged on for years.
A few 2024 approvals were also for assets that originated in China, including BeiGene’s Tevimbra (tislelizumab) for esophageal squamous cell carcinoma and Ensacove (ensartinib) for NSCLC, from Xcovery, a subsidiary of China’s Betta Pharmaceuticals.
China-originated approvals are a metric worth monitoring for companies and investors setting BD strategy in the region, a theme Sleuth tracks in its China biopharma landscape analysis.
Sleuth’s counts are as of December 27, 2024 and non-exhaustive. They exclude drugs approved through the 505(b)(2) pathway, diagnostics and source plasma, and the CBER list also excludes biosimilars and generics. FDA’s final 2024 CDER total of 50 was checked in September 2026. This page is a record of the 2024 approval year.
Frequently asked questions about 2024 FDA novel drug approvals
How many novel drugs did the FDA approve in 2024?
Sleuth counted 55 novel approvals in 2024 as of December 27: 47 from CDER and eight from CBER, excluding diagnostics, 505(b)(2) drugs and source plasma. FDA’s own CDER list totals 50 because it includes three imaging and diagnostic agents.
How did 2024 FDA approvals compare with 2023?
Sleuth’s 2024 count of 55 was about 22% below 2023’s 71 (55 CDER, 16 CBER). CDER’s 2023 total was the second highest in 30 years, behind 59 in 2018, and its 47 approvals in 2024 were in line with the 10-year average of 46.
What kinds of drugs did CDER approve in 2024?
Of the 47 CDER approvals on Sleuth’s 2024 list, 29 were small molecules, 13 antibodies, four other biologics and one an antisense oligonucleotide. Fourteen were cancer drugs, three of them for NSCLC.
Did any China-developed drugs win FDA approval in 2024?
Yes. Sleuth’s 2024 list includes BeiGene’s Tevimbra (tislelizumab) for esophageal squamous cell carcinoma, approved in March, and Ensacove (ensartinib) for NSCLC, approved in December, from Xcovery, a subsidiary of China’s Betta Pharmaceuticals.
