Beatriz Nunes Schiavon

Dr. Beatriz Nunes Schiavon

orcid

Research Focus & Metrics

Academic Career Length

2Years (2025-Present)

(Calculated once Scilit publication data is synced: current year − year of first publication + 1)

Representative Publications

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12 August 2025 in Biomedicines
Verified
Journal Article
Open access
PDF file
Alexander Carcelen MartinsAlexander Carcelen Martins
Alexander Carcelen Martins
Mariana Y OshiroMariana Y Oshiro
Mariana Y Oshiro
BSBeatriz Nunes Schiavon
Beatriz Nunes Schiavon
GJGlaucia A. de Jesus
Glaucia A. de Jesus
Beatriz G. de la TorreBeatriz G. de la Torre
Beatriz G. de la Torre
Fernando AlbericioFernando Albericio
Fernando Albericio
Advances in drug development continue to play a critical role in addressing diseases, including those with unmet medical needs. In 2024, the FDA approved 50 novel drugs, 16 of which were biologics. For context, during the first half of 2024 alone, the agency approved six biologics. By mid-2025, six additional biologics have received the green light, indicating that the pace of approvals of this class of drugs this year may be on par with 2024. This paper analyzes all biologics that received FDA authorization in 2024, examining their mechanisms, clinical trials, and expedited review pathways. Key approvals included the highest number of monoclonal antibodies (mAbs) since 2015 (13 mAbs, 6 indicated for oncology), while no antibody–drug conjugates were authorized—continuing with the trend in 2023. In addition, a new chimeric mAb has been approved since the last chimeric mAb approved in 2022, and a new mAb for Alzheimer’s disease. Nine biologics are first-in-class therapies, while ten received Orphan Drug Designation. The biologics considered herein fall into the categories of mAbs and proteins.