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Drug Manufacturer Indication Tezacaftor/ivacaftor [2] Vertex Pharmaceuticals: cystic fibrosis: Durvalumab [2] AstraZeneca UK: unresectable Stage III non-small cell lung cancer: Ibalizumab-uiyk [2] Theratechnologies: human immunodeficiency virus type 1 (HIV-1) infection Brentuximab vedotin [2] Seattle Genetics: Hodgkin lymphoma: Ipilimumab [2 ...
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage.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.
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.
The FDA said Zepbound’s approval for moderate to severe obstructive sleep apnea in adults with obesity is based on two placebo-controlled studies of 469 adults without type 2 diabetes.
The regulator approved the drug for moderate to severe obstructive sleep apnea in adults with obesity, the company said. ... The FDA's approval is based on data from two trials involving 469 ...
The weight loss drug Zepbound, generically known as tirzepatide, is also now an approved medication to treat obstructive sleep apnea, per a Food and Drug Administration Dec. 20 press release.
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.
Federal regulators are increasingly approving medicines before studies have shown they work, leaving patients at risk of taking prescriptions that could harm but not help them.
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