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This list is not limited to drugs that were ever approved by the FDA. Some of them (lumiracoxib, rimonabant, tolrestat, ximelagatran and ximelidine, for example) were approved to be marketed in Europe but had not yet been approved for marketing in the US, when side effects became clear and their developers pulled them from the market.
The center doesn't actually test drugs itself, although it does conduct limited research in the areas of drug quality, safety, and effectiveness standards. As of the end of 2013, the FDA and its predecessors had approved 1,452 drugs, though not all are still available, and some have been withdrawn for safety reasons. [5]
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage. See the list of FDA-approved therapeutic monoclonal antibodies in the monoclonal antibody therapy page.
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 ...
Drug Manufacturer Indication Crizotinib: PF Prism: ALK-positive systemic anaplastic large cell lymphoma: Trastuzumab deruxtecan: Daiichi Sankyo: HER2-positive gastric or gastroesophageal junction adenocarcinoma, previously treated with trastuzumab: Umbralisib: TG Therapeutics: marginal zone lymphoma, previously treated with an anti-CD20-based ...
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
The US Food and Drug Administration approved the medication Zepbound last week to treat chronic obesity. The injectable drug, made by the pharmaceutical company Eli Lilly, has the active ...
The FDA determines as part of the drug approvals process that a REMS is necessary, and the drug company develops and maintains the individual program. [2] REMS applies only to specific prescription drugs, but can apply to brand name or generic drugs. REMS for generic drugs may be created in collaboration with the manufacture of the brand name ...