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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.
Prior to the Prescription Drug User Fee Act (PDUFA), median approval times of New Drug Applications ranged between 21 and 29 months. [2] The Prescription Drug User Fee Act was first passed in 1992 to facilitate the funding of the Food and Drug Administration while ensuring a more predictable timetable for drug approvals. [3]
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2019, lesinurad was discontinued in the United States by its manufacturer for business reasons, and was subsequently withdrawn in Europe in July 2020.
The FDA has generally recommended switching studies to show evidence of interchangeability of a biosimilar. Regulatory reform is needed so patients can more easily access biosimilars and draw ...
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 ...
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.
(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 ...
NCI Drug Dictionary. Clinical trial number NCT04065399 for "A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation (AUGMENT-101)" at ClinicalTrials.gov; Clinical trial number NCT05918913 for "Expanded Access Program for Revumenib" at ClinicalTrials.gov