Evidence map›Paper›PMID 39335511›Full record

ReviewBiomedicines2024

Food and Drug Administration (FDA) Approvals of Biological Drugs in 2023.

Alexander C Martins, Mariana Y Oshiro, Fernando Albericio, Beatriz G de la Torre

Abstract readReview
In one paragraph

Review in Biomedicines, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing 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

10 citing papers in PubMed.

  1. Therapeutic peptides and proteins: Status and developments in drug delivery.Journal of controlled release : official journal of the Controlled Release Society · 2026
    Review
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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.

Alexander C MartinsSchool of Health Sciences, UAM, Universidade Anhembi-Morumbi, São Paulo 03101-001, Brazil.ORCID 0000-0002-7637-5410
Mariana Y OshiroSchool of Health Sciences, UAM, Universidade Anhembi-Morumbi, São Paulo 03101-001, Brazil.ORCID 0000-0002-4307-5761
Fernando AlbericioSchool of Chemistry and Physics, University of KwaZulu-Natal, Durban 4001, South Africa.ORCID 0000-0002-8946-0462
Beatriz G de la TorreKRISP, College of Health Sciences, University of KwaZulu-Natal, Durban 4001, South Africa.ORCID 0000-0001-8521-9172

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

An increase in total drug (small molecules and biologics) approvals by the Food and Drug Administration (FDA) was seen in 2023 compared with the previous year. Cancer remained the disease most targeted by monoclonal antibodies (mAbs), followed by autoimmune conditions. Our data reveal the prevalence of approvals for biologics even during years when the total number of authorizations was low, such as in 2022. Over half the drugs that received the green light in 2023 benefited from expedited programs, as the incidence of many diseases increased. In addition, over half of the biologics approved received Orphan Drug Designation from the FDA. This narrative review delves into details of the most significant approvals in 2023, including mAbs, enzymes, and proteins, explaining their mechanisms of action, differences from previous drugs, placebo, and standards of care, and outcomes in clinical trials. Given the varying number of drugs authorized annually by the U.S. health authority, this review also examines the limits of external influences over the FDA's decisions and independence regarding drug approvals and withdrawals.

Indexed as

Alzheimer′s diseaseamyloid-related imaging abnormalitiesbiologicscancerclinical trialsenzymesFDA approvedfirst approvalFood and Drug Administrationmonoclonal antibodyorphan drugresistance

Identifiers

PMID39335511
PMCPMC11428688

What OpenQuestion holds

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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.