Evidence map›Paper›PMID 38530400›Full record

ReviewNaunyn-Schmiedeberg's archives of pharmacology2024

A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2023.

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

Abstract readReview
In one paragraph

Review in Naunyn-Schmiedeberg's archives of pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Review
  2. Do GPCRs constitute the target of 30% of newly approved drugs in Germany?Naunyn-Schmiedeberg's archives of pharmacology · 2026
    Article
  3. Article
  4. Comparison of drug approvals of the FDA and EMA between 2013 and 2023.Naunyn-Schmiedeberg's archives of pharmacology · 2026
    Article
  5. Review
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, Langenbeckstr. 1, 55118, Mainz, Germany.
Martin C MichelDepartment of Pharmacology, University Medical Center, Johannes Gutenberg University, Langenbeckstr. 1, 55118, Mainz, Germany. marmiche@uni-mainz.de.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

With 54 new drugs and seven cellular and gene therapy products, the approvals by the US Food and Drug Administration (FDA) recovered 2023 from the 2022 dent back to the levels of 2020-2021. As in previous years of this annual review, we assign these new drugs to one of three levels of innovation: first drug against a condition ("first-in-indication"), first drug using a novel molecular mechanism ("first-in-class"), and "next-in-class," i.e., a drug using an already exploited molecular mechanism. We identify four (7%) "first-in-indication," 22 (36%) "first-in-class," and 35 (57%) "next-in-class" drugs. By treatment area, rare diseases (54%) and cancer drugs (23%) were once again the most prevalent (and partly overlapping) therapeutic areas. Other continuing trends were the use of accelerated regulatory approval pathways and the reliance on biopharmaceuticals (biologics). 2023 marks the approval of a first therapy based on CRISPR/Cas9 gene editing.

Indexed as

Drug ApprovalUnited States Food and Drug AdministrationAnimalsHumansUnited StatesFDAFirst-in-classNew drugsNext-in-class

Identifiers

PMID38530400
PMCPMC11074039

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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 OpenQuestion graph.