About 10 percent of serious and unexpected adverse events are not reported by drug manufacturers to the U.S. Food and Drug Administration under the 15-day timeframe set out in federal regulations, according to an article ...
Jul 27, 2015
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Australian medical tech manufacturer Ellume said it had recalled almost 200,000 at-home COVID-19 tests in the United States over an increased chance of false positives.
Oct 6, 2021
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US federal health inspectors said Monday they have uncovered serious problems at a second Massachusetts pharmacy run by some of the same people whose tainted drugs caused a deadly meningitis outbreak.
Nov 12, 2012
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The drug perampanel (trade name Fycompa) has been approved since July 2012 as adjunctive ("add-on") therapy for adults and children aged 12 years and older with epileptic fits (seizures). In a new early benefit assessment ...
Aug 19, 2014
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Vandetanib (trade name Caprelsa) has been approved in Germany since February 2012 for adult patients suffering from a particular form of aggressive thyroid cancer. The German Institute for Quality and Efficiency in Health ...
Nov 9, 2012
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The drug aclidinium bromide (trade names Eklira, Bretaris) has been approved since October 2012 for widening the narrowed airways of adults with chronic-obstructive pulmonary disease (COPD). The German Institute for Quality ...
Jan 30, 2013
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Safety decisions concerning one-third of the more than 10,000 substances that may be added to human food were made by food manufacturers and a trade association without review by the U.S. Food and Drug Administration (FDA), ...
Oct 26, 2011
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India's Health Ministry said Thursday it was examining charges that the government's top drug regulatory agency had colluded with pharmaceutical firms to approve drugs without proper clinical trials.
May 10, 2012
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The number of treatments for rare diseases affecting children has increased, a new study suggests. But federal incentives intended to encourage drug development for rare conditions are being used more often to expand the ...
Mar 3, 2020
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Vildagliptin (trade name Galvus or Jalra) has been approved since September 2007 for adults with type 2 diabetes mellitus in whom diet and exercise do not provide adequate glycaemic control. The German Institute for Quality ...
Mar 9, 2015
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