The US Food and Drug Administration (FDA) has detailed the new drugs it approved in 2025.
The FDA’s definition of "novel" are new drugs never before approved or marketed in the US.
The 46 new drugs approved in 2025 by the FDA’s Center for Drug Evaluation and Research (CDER) is slightly lower than in the last couple of years - in 2024, CDER approved 50 new drugs, in 2023 it was 55 new drugs. In 2022 CDER only approved 37 novel drugs, while in 2021 the number stood at 50.
Cancer and cardiology drugs were the most common new drugs approved. Seven of the approvals came in December alone.
The list does not contain vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, which are separately approved by the Center for Biologics Evaluation and Research.
In order of approval, the 46 novel drugs approved by the FDA by brand name with active ingredient in brackets are:
Datroway (datopotamab deruxtecan-dlnk)
Grafapex (treosulfan)
Journavx (suzetrigine)
Gomekli (mirdametinib)
Romvimza (vimseltinib)
Blujepa (gepotidacin)
Qfitlia (fitusiran)
Vanrafia (atrasentan)
Penpulimab-kcqx (penpulimab-kcqx)
Imaavy nipocalimab-aahu)
Avmapki Fakzynja Co-Pack (avutometinib and defactinib)
Emrelis (telisotuzumab vedotin-tllv)
Tryptyr (acoltremon)
Enflonsia (clesrovimab-cfor)
Ibtrozi (taletrectinib)
Andembry (garadacimab-gxii)
Lynozyfic (linvoseltamab-gcpt)
Zegfrovy (sunvozertinib)
Ekterly (sebetralstat)
Anzupgo (delgocitinib)
Sephience (sepiapterin)
Vizz (aceclidine)
Modeyso (dordaviprone)
Hernexeos (zongertinib)
Brinsupri (brensocatib)
Dawnzera (donidalorsen)
Wayrilz (rilzabrutinib)
Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph)
Forzinity (elamipretide)
Inluriyo (imlunestrant)
Palsonify (paltusotine)
Rhapsido (remibrutinib)
Jascayd (nerandomilast)
Lynkuet (elinzanetant)
Kygevvi (doxecitine and doxribtimine)
Komzifti (ziftomenib)
Redemplo(plozasiran)
Hyrnuo (sevabertinib)
Voyxact (sibeprenlimab-szsi)
Lerochol (lerodalcibep-liga)
Nuzolvence (zoliflodacin)
Cardamyst (etripamil)
Exdensur (depemokimab-ulaa)
Myqorzo (aficamten)
Yartemlea (narsoplimab-wuug)
Nereus (tradipitant)
You can find the list of the new drugs approved by the FDA in 2024 here.
Further reading on pharmaceuticals
- AI in pharma: Helping science to find drugs faster
- Critical Medicines Act moves forward as Europe seeks to tackle shortages
- Life sciences: Why execs are cautiously optimistic about 2026
- EU Biotech Act: Europe's plan to catch-up with the competition
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