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The FDA required Takeda to conduct this safety study when the medicine was approved in 2009. The febuxostat drug labels already carry a warning and precaution about cardiovascular events because the clinical trials conducted before approval showed a higher rate of heart-related problems in patients treated with febuxostat compared to allopurinol.
It received FDA approval on 22 December 2015. [3] The European Commission granted a marketing authorisation valid throughout the European Union on 18 February 2016. [ 4 ] In February 2019, lesinurad was discontinued in the United States by its manufacturer for business reasons, and was subsequently withdrawn in Europe in July 2020.
Prasugrel, sold under the brand names Effient and Efient, is a medication used to prevent formation of blood clots.It is a platelet inhibitor and an irreversible antagonist of P2Y 12 ADP receptors and is of the thienopyridine drug class.
(Reuters) -The U.S. Food and Drug Administration on Monday delayed traditional approval for Liquidia Corp's inhaled drug for types of lung disorders, and allowed only tentative clearances, sending ...
The popular weight-loss drug Wegovy, which has helped millions of Americans shed pounds, can now be used to reduce the risk of stroke, heart attacks and other serious cardiovascular problems in ...
(Reuters) -The U.S. Food and Drug Administration granted accelerated approval to French drugmakers Ipsen and Genfit's drug for a chronic inflammatory liver disease, Iqirvo, the companies said on ...
Vadadustat, sold under the brand name Vafseo, is a medication used for the treatment of symptomatic anemia associated with chronic kidney disease. [2] [3] Vadadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor.
The treatment, Tivdak - an antibody-drug conjugate co-developed by Genmab A/S and Seagen - received the FDA's accelerated approval for the same indication in 2021. It was added to Pfizer's ...