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In May 2019, the FDA approved two tafamidis preparations, Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis), for the treatment of transthyretin-mediated cardiomyopathy. [7] The drug was approved in Japan in 2013; regulators there made the approval dependent on further clinical trials showing better evidence of efficacy. [17]
In late 2011, the European Medicines Agency approved the transthyretin kinetic stabilizer Tafamidis or Vyndaqel discovered by Jeffery W. Kelly and developed by FoldRx pharmaceuticals (acquired by Pfizer in 2010) for the treatment of FAP based on clinical trial data. Tafamidis (20 mg once daily) slowed the progression of FAP over a 36-month ...
They estimate a market of 35,000 patients in the U.S. and Europe, with an additional 23,000 in some countries in the Middle East where Casgevy is also approved.
After a split vote by a Food and Drug Administration advisory panel, the agency will have the final say on whether Pfizer's (NYS: PFE) tafamidis meglumine is approved in the U.S. The decision won ...
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage.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.
(Reuters) -Alnylam Pharmaceuticals said on Monday it would not pursue expanded use of its drug to treat a potentially fatal heart disease in the U.S. after the Food and Drug Administration ...
This multi-page article lists pharmaceutical drugs alphabetically by name. Many drugs have more than one name and, therefore, the same drug may be listed more than once. Brand names and generic names are differentiated by capitalizing brand names. See also the list of the top 100 bestselling branded drugs, ranked by sales.
Amyloidosis, hemophilia, and endocrine diseases under the Vyndaqel/Vyndamax, BeneFIX, and Genotropin brands. Pfizer anticipates full-year 2025 revenues in the range of $61.0 to $64.0 billion. This ...