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Belimumab, sold under the brand name Benlysta, is a human monoclonal antibody that inhibits B-cell activating factor (BAFF), [6] also known as B-lymphocyte stimulator (BLyS). [7] It is approved in the United States [8] and Canada, [9] and the European Union [5] to treat systemic lupus erythematosus and lupus nephritis. [10]
Hydroxychloroquine was approved by the FDA for lupus in 1955. [120] Some drugs approved for other diseases are used for SLE 'off-label'. In November 2010, an FDA advisory panel recommended approving belimumab (Benlysta) as a treatment for the pain and flare-ups common in lupus. The drug was approved by the FDA in March 2011. [121] [122]
The PDUFA date serves as a good first approximation of when a final decision on drug approval can be expected. Sponsors frequently publish PDUFA dates for their pending applications, [1] and while there is no official list of PDUFA dates, [10] several websites collect PDUFA dates from press announcements in a calendar form. [11]
According to the drug’s website, results from a six-month study with 703 adults with type 2 diabetes compared 7 mg and 14 mg Rybelsus with a sugar pill when both were taken with adjustments to ...
The U.S. Food and Drug Administration (FDA) on Tuesday published letters warning two online vendors to stop selling unapproved versions of semaglutide and tirzepatide, the active ingredients in ...
In September 2019, a version that can be taken orally (Rybelsus) was approved for medical use in the United States, [70] [71] and in the European Union in April 2020. [ 18 ] In June 2021, a higher-dose version for injectable use sold under the brand name Wegovy was approved by the FDA as an anti-obesity medication for long-term weight ...
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Since lupus nephritis is a serious, disabling, and possibly life-threatening illness, it is not surprising to see mortality in lupus nephritis clinical trials. Voclosporin safety information originates from a total of 267 patients who received 23.7 mg BID and an additional 88 patients who received 39.5 mg BID.