2022 in review: FDA approvals of new medicines

Michael S. Kinch; Zachary Kraft; Tyler Schwartz

doi:10.1016/j.drudis.2023.103622

2022 in review: FDA approvals of new medicines

Michael S. Kinch
, Zachary Kraft
, Tyler Schwartz

Office for Research and Innovation

Long Island University

Research output: Contribution to journal › Short survey › peer-review

6 Scopus citations

Abstract

An accounting of all new entities approved by both the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) identified the approval of 44 new entities in the year 2022. Oncology-based drugs continued to be the most popular indication for these medicines. Likewise, orphan indications encompassed more than half of new drug approvals. The number of new entities approved in 2022 declined from its peak after 5 years of more than 50 annual approvals. Likewise, the rate of consolidations slowed somewhat, among both new entries in the realm of clinical-stage developers and more established organizations.

Original language	English
Article number	103622
Journal	Drug Discovery Today
Volume	28
Issue number	8
DOIs	https://doi.org/10.1016/j.drudis.2023.103622
State	Published - Aug 2023

Keywords

biotechnology
FDA
new molecular entities
pharmaceutical

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10.1016/j.drudis.2023.103622

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title = "2022 in review: FDA approvals of new medicines",

abstract = "An accounting of all new entities approved by both the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) identified the approval of 44 new entities in the year 2022. Oncology-based drugs continued to be the most popular indication for these medicines. Likewise, orphan indications encompassed more than half of new drug approvals. The number of new entities approved in 2022 declined from its peak after 5 years of more than 50 annual approvals. Likewise, the rate of consolidations slowed somewhat, among both new entries in the realm of clinical-stage developers and more established organizations.",

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year = "2023",

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AU - Kraft, Zachary

AU - Schwartz, Tyler

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N2 - An accounting of all new entities approved by both the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) identified the approval of 44 new entities in the year 2022. Oncology-based drugs continued to be the most popular indication for these medicines. Likewise, orphan indications encompassed more than half of new drug approvals. The number of new entities approved in 2022 declined from its peak after 5 years of more than 50 annual approvals. Likewise, the rate of consolidations slowed somewhat, among both new entries in the realm of clinical-stage developers and more established organizations.

AB - An accounting of all new entities approved by both the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) identified the approval of 44 new entities in the year 2022. Oncology-based drugs continued to be the most popular indication for these medicines. Likewise, orphan indications encompassed more than half of new drug approvals. The number of new entities approved in 2022 declined from its peak after 5 years of more than 50 annual approvals. Likewise, the rate of consolidations slowed somewhat, among both new entries in the realm of clinical-stage developers and more established organizations.

KW - biotechnology

KW - FDA

KW - new molecular entities

KW - pharmaceutical

UR - https://www.scopus.com/pages/publications/85159864094

U2 - 10.1016/j.drudis.2023.103622

DO - 10.1016/j.drudis.2023.103622

M3 - Short survey

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AN - SCOPUS:85159864094

SN - 1359-6446

VL - 28

JO - Drug Discovery Today

JF - Drug Discovery Today

IS - 8

M1 - 103622

ER -

2022 in review: FDA approvals of new medicines

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Keywords

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