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Luspatercept, sold under the brand name Reblozyl, is a medication used for the treatment of anemia in beta thalassemia and myelodysplastic syndromes. [ 5 ] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication .
Roxadustat is reported to increase VEGF, a signal protein that can activate tumor growth [8] and also is considered to cause pulmonary hypertension. [9] In phase 3 trial conducted at 29 sites in China, roxadustat treatment was found to cause hyperkalemia, i.e., increase in serum potassium, and metabolic acidosis in patients.
Luspatercept is a TGFβ ligand that acts to decrease SMAD2 and SMAD3 signaling involved in erythropoeisis and may be used in MDS with anemia that is not responsive to erythrocyte stimulating agents or mild MDS with ring sideroblasts. Luspatercept was shown to decrease the need for transfusions and this effect lasted for a median of 30.6 weeks.
The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012.It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics.
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage.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.
Type approval or certificate of conformity is granted to a product that meets a minimum set of regulatory, technical and safety requirements. Generally, type approval is required before a product is allowed to be sold in a particular country, so the requirements for a given product will vary around the world.
approval of the Project complied with the Endangered Species Act with respect to North Atlantic Right Whales and sea turtles. Section III responds to arguments raised by the Wampanoag Tribe of Gay Head (Aquinnah) based on the National Historic Preservation Act and the National Environmental Policy Act.
MDS information is transmitted electronically by nursing homes to the MDS database in their respective states. MDS information from the state databases is captured into the national MDS database at Centers for Medicare and Medicaid Services (CMS). Sections of MDS (Minimum Data Set): Identification Information; Hearing, Speech and Vision