NANJING, June 7 (Xinhua) -- China Food and Drug Administration (FDA) has approved the sale of a new drug for the treatment of HIV-1 infection, the maker of the drug said. Aikening, or albuvirtide for injection (ABT), can be used with other antiretroviral drugs to treat infected patie...
通过阅读文章可知,文章首段内容“Now, the Food and Drug Administration(FDA) has approved two drugs that may slow the cognitive decline destroying the lives of millions of Alzheimer’s patients.(现在,美国食品药品监督管理局(FDA)批准了两种药物,这两种药物可能会减缓认知能力下降,从而摧毁数百万阿尔茨海默...
It is heartening to observe that the FDA has granted approved three innovative Chinese new drugs: Loqtorzi (toripalimab), Fruzaqla (fruquintinib) and Ryzneuta (efbemalenograstim). Toripalimab is a monoclonal antibody targeting PD-1, marks the first FDA-approved drug for the treatment of...
He also suggested that FDA approval of China PD-1/PD-L1 candidates based on development programs that mimicked FDA-approved products would be smooth. “Obviously, they could have very similar results, so we would have very little to say in the approval of these drugs.” So far, four PD-...
The latest news regarding FDA applications, processes, and approval. This section contains releases regarding the Food and Drug Administration’s consideration of new products, drugs, therapies and treatments. Find announcements covering every stage of the FDA application process, from filing to eventual...
链接:https://www.fda.gov/drugs/develo ... lesdmfs/default.htm 4. FDA溶出度数据库(研发神器) 对美国药典(USP)未收录的溶出试验方法,FDA溶出度数据库提供了生物等效性、仿制药办公室目前建议的溶出度方法,每个季度更新。 此链接可以查找溶出度数据库(了解溶出条件、取样时间点)、溶出度Q&A,对制剂研发工作者...
Withpenpulimab's domestic approval in August, there are now five PD-1 drugs approved in China, including Shanghai Junshi Biosciences Co. Ltd.'s Tuo Yi—the first drug in this class launched in the country— which the company submitted to ...
/PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Ctexli (chenodiol) for the treatment of cerebrotendinous xanthomatosis (CTX) in adults...
Significant weight loss is also seen with Mounjaro, even though it's not approved for that use.In studies up to 52-weeks, when Mounjaro was used alone or with diabetes drugs, adults lost from 12 lb (5.5 kg) to 25 lb (11.4 kg) with the 5, 10 or 15 mg dose injected subcutaneously...
[1] FDA approves brentuximab vedotin with lenalidomide and rituximab for relapsed or refractory large B-cell lymphoma. Retrieved February 12, 2025, from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-vedotin-lenalidomide-and-rituximab-relapsed-or-refractory-large...