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...
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
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, ...
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...
In July 2022, China NMPA approved10 new drugs, including 8 chemical drugs and 2 biological products. Among the drugs,Genuine Biotech’s Azvudine Tabletsis the first homegrown oral drug to get NMPA’s approval for COVID-19 treatment.
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
One spur: a continuing decline in the number of new drug approvals by large pharmaceutical companies. 造成这一现象的原因之一是,大型制药公司获准上市销售的新药持续减少。 blog.sina.com.cn 2. This broader definition of new drug approvals is less meaningful; 扩大新药批准的定义没有实质意义; dictsear...
Despite the pressures and added regulatory challenges imposed by the COVID-19 pandemic, and the uproar over its surprise approval of Biogen’s new Alzheimer’s therapy Aduhelm, FDA is on track this year to authorize a notable number of new molecular entities (NMEs) and important biotech ...
*”First generic drug in China” refers to the first generic drug developed by Chinese companies and approved by China National Medical Products Administration (NMPA). Technically, generic drugs are not innovative/improved drugs according to Chinese drug regulations. Yet, first generics are still incl...