Search results
Results from the WOW.Com Content Network
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]
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage.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.
CAT was also behind belimumab, the anti-BlyS antibody drug marketed as Benlysta and the first new approved drug for systemic lupus in more than 50 years. [1] In 2018, the Nobel Prize organisation awarded one quarter of the Nobel Prize in Chemistry to a founding member of CAT, Sir Greg Winter FRS "for the phage display of peptides and antibodies ...
A few years ago, all a biotech had to do see large sustained gains was get its drug approved. Nothing else really mattered. Not anymore -- sales of newly approved drugs are no longer a foregone ...
Food and Drug Administration review times usually offer little in the way of a hint at the likelihood of approval. Sometimes drugs are given a priority review because they treat an unmet need and ...
The first FDA-approved therapeutic monoclonal antibody was a murine IgG2a CD3 specific transplant rejection drug, OKT3 (also called muromonab), in 1986. This drug found use in solid organ transplant recipients who became steroid resistant. [39] Hundreds of therapies are undergoing clinical trials. Most are concerned with immunological and ...
The Food and Drug Administration on Friday approved Pfizer’s treatment for a rare genetic bleeding disorder, making it the company’s first-ever gene therapy to win clearance in the U.S.
In November 2022, GSK plc initiated the process for withdrawal of the United States marketing authorization for belantamab mafodotin following the request of the US FDA. [9] This request was based on the outcome of the DREAMM-3 phase III confirmatory trial, [10] which did not meet the requirements of the US FDA accelerated approval regulations ...