Search results
Results from the WOW.Com Content Network
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2019, lesinurad was discontinued in the United States by its manufacturer for business reasons, and was subsequently withdrawn in Europe in July 2020.
In January 2006, the U.S. Food and Drug Administration (FDA) approved the use of Exubera, a form of inhalable insulin developed by Pfizer. [3] It was approved in the UK in August 2006 but reimbursed by the National Health Service only for people who had problems with needles. [8] It was not reimbursed by any US insurer. [9]
The FDA on Monday once again granted tentative approval to yutrepia for PAH, as well as for PH-ILD, after the health regulator said it was still reviewing Liquidia's marketing application in January.
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 ...
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...
US FDA approves Amgen drug for small cell lung cancer. May 17, 2024 at 10:56 AM (This May 16 story has been officially corrected to change the pricing estimate in paragraph 4)
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.