The U.S. Justice Department on Monday appealed a Texas court ruling that invalidates the U.S. Food and Drug Administration approval in 2020 of mifepristone, the first of two drugs taken during a medical abortion.
Apr 12, 2023
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Medicare will soon cover a new class of Alzheimer's drugs if they receive full approval from the U.S. Food and Drug Administration, with some key limits.
Jun 2, 2023
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Of high-risk therapeutic devices approved via the Food and Drug Administration (FDA) Premarket Approval (PMA) pathway between 2010 and 2011, there has been wide variation in both the number and quality of premarket and postmarket ...
Aug 11, 2015
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In its first year of implementation, the RACE Act has resulted in increased requirements for more recently approved cancer drugs to be studied for potential use in pediatric patients, according to data presented at the AACR ...
Apr 11, 2022
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Bristol-Myers Squibb, one of the world's largest drugmakers, will team up with a Dutch biotechnology company whose first approved drug could cost more than $1 million.
Apr 6, 2015
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In the first installment of a new series, Peter Doshi, Assistant Professor at the University of Maryland School of Pharmacy and Associate Editor at The BMJ, asks why authorities are approving drugs with little evidence they ...
Mar 26, 2015
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Liver-on-a-chip devices capture the physiological and mechanical properties of the liver. They are commonly used by researchers to study how the liver metabolizes different compounds and drugs. In a new study seen in ACS ...
Jul 28, 2021
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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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A federal appeals court has ruled that Novartis can begin selling its lower-cost copy of an Amgen Inc. drug in September, rejecting a bid to further delay the launch of the knock-off biotech medication.
Jul 21, 2015
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The U.S. Food and Drug Administration has approved Talvey (talquetamab-tvgs) for patients with relapsed or refractory multiple myeloma.
Aug 16, 2023
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