As the industry enters the fourth quarter, how do new drug approvals by FDA’s Center for Drug Evaluation and Research stand now and comparative to recent trends? What is the mix between small molecules and biologics? DCAT Value Chain Insights looks at the products and companies.

By Patricia Van Arnum, Editorial Director, DCAT, pvanarnum@dcat.org

New drug approvals thus far in 2025
With staffing and budgetary cuts at the US Food and Drug Administration (FDA), an important question for the industry thus far in 2025 is have those cuts had an impact on drug approvals. Drug approvals do not follow a strict chronological path, so a comparison of the number of drug approvals at a given point in time has its limitations. That comparison, however, can serve as broad guidepost in measuring the level of innovation in the industry.   

The verdict as the industry nears the fourth quarter 2025 is that new drug approvals by FDA are down from 2024 and 2023 thus far in 2025. For purposes of this analysis, the comparison was made based on new drug approvals from FDA’s Center for Drug Evaluation and Research (CDER), which reviews and approves new molecular entities and new biological therapeutics. Other biologic-based products, including blood products, vaccines, allergenics, tissues, and cellular and gene therapies, are reviewed and approved by a separate center within FDA, the Center for Biologics Evaluation and Research (CBER), and are not part of this analysis. Additionally, new drugs approvals for 2025 were based on approvals through September 25, 2025 (as of press time for this article), but for prior years, the analysis was done through the end of September in a given year.  

Given that framework, the numbers show that through September 25, 2025, FDA’s CDER had approved 30 new molecular entities and biological therapeutics, compared to 34 approvals through September 27, 2024, which had 50 new drug approvals in the full-year 2024, and 40 new drug approvals through September 29, 2023, when 55 new drugs were approved in the full year 2023. In 2022, which was a recent low in new drug approvals with 37 new drug approvals for the full year, 26 new molecular entities and biological therapeutics were approved by FDA’s CDER through September 20, 2025. In 2021, 40 new drugs had been approved by FDA’s CDER through September 29, 2021 en route to 50 new drug approvals in 2021.

Small molecules versus biologics
In terms of product mix, of the 30 new molecular entities and biological therapeutics approved by FDA’s CDER thus far in 2025 (as of September 2025), small molecules once again dominated approvals, consistent with recent trends. Small molecules accounted for 22, or 73%, of new drug approvals by FDA’s CDER thus far in 2025, and biologics (which included two antibody drug conjugates) accounted for eight new approvals, or 27%, of new drug approvals by FDA’s CDER. The 27% for biologic approvals thus far in 2025 is slightly down from prior years but in line with a general 70/30% split (small molecules/biologics) of recent full-year new drug approvals by FDA’s CDER.

In looking at prior year trends, of the 50 new drug approvals by FDA’s CDER in 2024, 34, or 68%, were small molecules (31 drugs and three diagnostic/imaging agents), and 16, or 32%, were biologics. That was on par with the mix in 2023, when FDA’s CDER approved 17 new biological therapeutics, which represented 31% of new drug approvals, and 38 small-molecule products, or 69% of new drug approvals. However, small-molecule approvals in 2024 and 2023 dipped and were below recent historical levels when small-molecule drug approvals averaged 75% of new drug approvals between 2019 and 2021, with 2022 being an outlier with only 37 new drug approvals overall and only 59% being small molecules.

Biologics approvals thus far in 2025
In looking at the eight biologics approved thus far in 2025 by FDA’s CDER, two were antibody drug conjugates (ADCs): AbbVie’s Emrelis (telisotuzumab vedotin) and AstraZeneca’s/Daiichi Sankyo’s Datroway (datopotamab deruxtecan). AbbVie was granted accelerated approved by FDA for Emrelis in May (May 2025) for treating a certain form of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). Specifically, the drug was approved for patients with metastatic, non-squamous NSCLC with high c-Met protein overexpression who have received a prior systemic therapy.

Emrelis is AbbVie’s first internally developed solid tumor medicine, its first solid tumor FDA approval in lung cancer, and its second FDA-approved ADC. Its other commercial ADC, Elahere (mirvetuximab soravtansine-gyxn) for treating ovarian cancer, was gained by its $10.1-billion acquisition of ImmunoGen in early 2024.

In January (January 2025), AstraZeneca and Daiichi Sankyo received FDA approval for Datroway (datopotamab deruxtecan) for treating certain forms of breast cancer. Datroway is the second ADC approved from a collaboration between AstraZeneca and Daiichi Sankyo. The other ADC from that collaboration is Enhertu (trastuzumab deruxtecan) for treating HER2-positive breast cancer, which is one of the top-selling ADCs. In 2024, Enhertu’s combined sales by AstraZeneca and Daiichi Sankyo reached $3.75 billion.

Merck & Co. has had two biologics approved thus far in 2025 by FDA’s CDER: Enflonsia (clesrovimab-cfor) for treating respiratory syncytial virus lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) to treat adult and pediatric (12 years and older) in solid tumor indications approved for the subcutaneous administration formulation of pembrolizumab, the active ingredient in the company’s blockbuster immuno-oncology drug, Keytruda. The subcutaneous injection of Keytruda Qlex may provide added convenience compared to intravenous administration of the drug because it can be administered by healthcare providers in multiple settings from an infusion center to a doctor’s office or a local community-based clinic, providing more options where patients can receive their treatment and also provides flexibility in treatment administration in terms of time for administration, according to information from Merck in announcing the drug approval.

Another biologic approved thus far in 2025 by a large pharma company is Johnson & Johnson’s Imaavy (nipocalimab-aahu) for treating generalized myasthenia gravis, a rare autoimmune disorder characterized by loss of muscle function and severe muscle weakness. The drug is approved for treating adults and children 12 years of age and older with generalized myasthenia gravis who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive. It is a monoclonal antibody designed to bind with high affinity to block FcRn and reduce levels of circulating immunoglobulin G (IgG) antibodies that underlie generalized myasthenia gravis without additional detectable effects on other adaptive and innate immune functions. Nipocalimab also is being investigated across three key segments in the autoantibody space, including rare autoantibody diseases, maternal fetal diseases mediated by maternal alloantibodies, and rheumatic diseases. The company projects potential peak sales of the drug of $5 billion.

Other biologics approval by FDA’s CDER thus far in 2025 include: Akeso’s penpulimab-kcqx (penpulimab-kcqx) for treating recurrent or metastatic non-keratinizing nasopharyngeal carcinoma; CSL Behring’s Andembry (garadacimab-gxii) for treating hereditary angioedema; and Regeneron’s Lynozyfic (linvoseltamab-gcpt) for treating relapsed or refractory multiple myeloma.