FDA new drug approvals in Q2 2023doi:10.1038/d41573-023-00117-6Lisa UrquhartNature Publishing Group UKNature Reviews Drug Discovery
new biological products, gene and cell therapies, new vaccines, and new traditional Chinese medicines approved for the first time in mainland China. Chemical drugs accounted for the largest proportion of new drug approvals (72, or 69.2
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 o...
After 2022 produced just 37 new drug approvals—the fewest by the FDA since 2016—the United States regulatorsigned offon a bumper crop of 55 new drugs in 2023. The list was the second longest in FDA history, coming up just shy of the single-year record of 59 approvals, w...
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要点 GBI this month reviews new drug approval trends in China during H1 2024. The first six months of this year have seen China’s macro-economic slowdown bottom-out, while the impact of the less-than-buoyant financial conditions for domestic biotechs is evident in the changing composition of...
The traditional regulatory drug approval paradigm comprising discrete phases of clinical testing that culminate in a large randomized superiority trial has historically been predominant in oncology. However, this approach has evolved in the current era o
1. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2021 2. https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/2021-biological-license-application-approvals ...
A comprehensive list of the US FDA’s Center for Drug Evaluation & Research (CDER)'s new drug therapy approvals for 2022. CDER approved 37 new drugs in 2022, down from50 in 2021, either as new molecular entities (NMEs) under New Drug Applications (NDAs), or as new therapeutic biologics...
The past year was a return to form for approvals of new drugs by the US Food and Drug Administration. There were 55 new molecular entities that cleared the FDA's hurdles in 2023. That number is up dramatically from the 37 the agency approved in 2022 and similar to the pace the agency...