Evidence mapPaperPMID 41807809Full record

ReviewNaunyn-Schmiedeberg's archives of pharmacology2026

A year in pharmacology: new drugs approved by the US food and drug administration in 2025.

Gizem Kayki-Mutlu, Zinnet Sevval Aksoyalp, Leszek Wojnowski, Martin C Michel

Abstract readReview
In one paragraph

Review in Naunyn-Schmiedeberg's archives of pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Gizem Kayki-Mutlu *Department of Pharmacology, Faculty of Pharmacy, Ankara University, Ankara, Türkiye.
Zinnet Sevval Aksoyalp *Department of Pharmacology, Faculty of Pharmacy, Izmir Katip Celebi University, Izmir, Türkiye.
Leszek WojnowskiDepartment of Pharmacology, University Medical Center, Johannes Gutenberg University, Mainz, Germany.
Martin C MichelDepartment of Pharmacology, University Medical Center, Johannes Gutenberg University, Mainz, Germany. marmiche@uni-mainz.de.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The US Food and Drug Administration approved 45 new drugs and 4 new cellular and gene therapy products in 2025, that is, a total of 49 new medical therapies. Oncology, hematology/immunotherapy, and cardiovascular/respiratory drugs remain most frequent. Among oncology drugs, there is a trend for targeting ever smaller subtypes of malignancies and/or rarer malignancies. Trends over the past 6 years include steady levels of first-in-indication (about 10%), first-in-class (about 38%), and next-in-class (about 51%) approvals. Along with a large share of approvals in orphan indications (> 50%), fast track approval pathways are now regularly representing more than half of all new approvals. While small molecules remain the bedrock of novel medical treatments (about 60%), there is a growing segment of mRNA, gene, and cell-based pharmacological approaches. These data testify to the innovative strength of academia, biotechnology, and established pharmaceutical companies in providing innovative treatments, often related to previously unmet medical needs.

Indexed as

Drug ApprovalAnimalsHumansUnited StatesUnited States Food and Drug AdministrationCell-based therapyFirst-in-classGene therapyMonoclonal antibodyNew drugsNext-in-classOrphan drugsRare diseases

Identifiers

PMID41807809
PMCPMC13269308

What Socratic holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.