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In the United States, the FDA approves drugs. Before a drug can be prescribed, it must undergo the FDA's approval process. While a drug can feasibly be used off-label (for non-approved indications), it still is required to be approved for a specific disease or medical condition. Drug companies seeking to sell a drug in the United States must ...
Alpidem (Ananxyl) 1995. Worldwide. Not approved in the US, withdrawn in France in 1994 [4] and the rest of the market in 1995 because of rare but serious hepatotoxicity. [3] [5] Alosetron (Lotronex) 2000. US. Serious gastrointestinal adverse events; ischemic colitis; severe constipation. [2]
In early 2023, the U.S. Food and Drug Administration (FDA) granted accelerated approval to a new Alzheimer’s drug called Leqembi. (Biogen, a biotechnology company, and Eisai, a pharmaceutical ...
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...
The U.S. Food and Drug Administration on Thursday granted accelerated approval to Amgen's tarlatamab, a targeted immunotherapy for adults in the advanced stages of hard-to-treat small cell lung ...
The FDA has approved a new drug for some adult patients with endometrial cancer. Jemperli (dostarlimably) — made by U.K. company GSK — is intended for primary advanced or recurrent disease.
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