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Sotatercept, sold under the brand name Winrevair is a medication used for the treatment of pulmonary arterial hypertension. [6] It is an activin signaling inhibitor, [ 6 ] based on the extracellular domain of the activin type 2 receptor expressed as a recombinant fusion protein with immunoglobulin Fc domain (ACTRIIA-Fc). [ 9 ]
Winrevair, which costs around $238,000 annually, was the first treatment to secure approval from the U.S. Food and Drug Administration from a class of drugs, which target a type of protein called ...
The therapy, branded Winrevair, is approved for treating pulmonary arterial hypertension (PAH), which affects about 40,000 people in the United States. US FDA approves Merck's therapy for rare ...
Research shows the drug increases bone formation and decreases bone resorption in postmenopausal women with low bone density. Romosozumab was approved for medical use in Japan, the United States and the European Union in 2019. [7] [10] [11] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [12]
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage.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.
While the company has not yet applied for approval from the U.S. Food and Drug Administration, a potential nod could make seralutinib a rival to Merck's Winrevair, which secured the agency's ...
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[citation needed] The new requirements include a section called Highlights which summarizes the most important information about benefits and risks; a Table of Contents for easy reference; the date of initial product approval; and a toll-free number and Internet address to encourage more widespread reporting of information regarding suspected ...
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