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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2019, lesinurad was discontinued in the United States by its manufacturer for business reasons, and was subsequently withdrawn in Europe in July 2020.
Febuxostat is only recommended in those who cannot tolerate allopurinol. [71] There are concerns about more deaths with febuxostat compared to allopurinol. [72] Febuxostat may also increase the rate of gout flares during early treatment. [73] However, there is tentative evidence that febuxostat may bring down urate levels more than allopurinol ...
The fires have blazed across tens of thousands of acres, swallowing homes, devouring communities and scarring Los Angeles for 10 unending days. They left an ashy trail of destruction, toxins and ...
In adults, GH therapy has been FDA-approved to treat GHD and HIV-related muscle loss. What causes growth hormone deficiency? GHD is a relatively rare condition. Slowed growth, short stature, and ...
Robert F. Kennedy Jr., who's nominated to become the next health secretary, asked the federal government to revoke its authorization of all COVID-19 vaccines in May 2021, just as vaccinated ...
The FDA reviews the data and if the product is seen as having a positive benefit-risk assessment, approval to market the product in the US is granted. [91] A fourth phase of post-approval surveillance is also often required due to the fact that even the largest clinical trials cannot effectively predict the prevalence of rare side-effects.
(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 ...