Federal regulators on Monday granted tentative approval to the first drug for muscular dystrophy, following an intense public campaign from patients and doctors who pushed for the largely unproven medication.
Sep 19, 2016
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New research has shown that the corticosteroid deflazacort is a safe and effective treatment for Duchenne muscular dystrophy. The findings, which appear this month in the journal Neurology, could pave the way for first U.S.-approved ...
Sep 9, 2016
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The reporting of trials of orlistat in the 1990s appears to have understated harms, both in the summarized results submitted to the European Medicines Agency for drug approval, and in the published papers, according to a ...
Aug 16, 2016
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At the beginning of August, the European Medicines Agency (EMA) published a report on a pilot project of a new accelerated path for drug approval (adaptive pathways). In this approval procedure, for a highly restricted population ...
Aug 9, 2016
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The second-biggest selling drug in the world could get some cheaper competition in the U.S., after a federal panel endorsed an alternative version of the pricey medication used to treat rheumatoid arthritis and other inflammatory ...
Jul 12, 2016
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A drug to treat severe postpartum depression showed positive results in a mid-stage study, sending shares developer Sage Therapeutics skyrocketing Tuesday.
Jul 12, 2016
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Federal health officials on Tuesday approved the first pill to treat all major forms of hepatitis C, the latest in a series of drug approvals that have reshaped treatment of the liver-destroying virus.
Jun 28, 2016
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(HealthDay)—Use of the word "breakthrough" in the U.S. Food and Drug Administration's expedited approval process could mislead doctors about the new drugs' actual benefits, researchers warn.
Apr 12, 2016
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(HealthDay)—The much-touted "female libido" pill seems to cause a host of serious side effects while failing to spark much additional passion in a woman's life, a new review suggests.
Feb 29, 2016
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As the year comes to an end, a survey of the hottest pharma news stories from the past year illustrates industry trends from megadeals to drug approvals. A suite of stories in Chemical & Engineering News (C&EN), the weekly ...
Dec 9, 2015
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