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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 ...
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage.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 February 2020, bempedoic acid was approved for use in the United States both as a standalone drug (brand name Nexletol) [5] [17] [18] [19] and in a fixed-dose combination with ezetimibe (brand name Nexlizet). [20] The U.S. Food and Drug Administration (FDA) granted the approval of Nexletol to Esperion Therapeutics. [2] [5]
U.S. regulators on Thursday approved the first drug to treat COVID-19: remdesivir, an antiviral medicine given to hospitalized patients through an IV.
Participants administered oliceridine reported decreased pain compared to placebo at the approved doses. [3] The U.S. Food and Drug Administration (FDA) approved oliceridine based on evidence from three clinical trials (Trial 1/NCT02815709, Trial 2/NCT02820324 and Trial 3) of 1558 participants 18 to 89 years old who were in need of pain ...
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. [2] Drug companies seeking to sell a drug in the United States must first test it.
Risdiplam was approved by the US Food and Drug Administration (FDA) in August 2020, for the treatment of adults and children two months of age or older. [6] [11] Developed by Roche in Basel, Switzerland, [12] in association with PTC Therapeutics and the SMA Foundation, [9] [11] it is marketed in the US by Genentech, [6] a subsidiary of Roche. [11]
Sacituzumab govitecan was approved for medical use in the United States in April 2020, [12] [13] [15] and in the European Union in November 2021. [10] The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) consider it to be a first-in-class medication. [16] [17]
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