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DailyMed is a website operated by the U.S. National Library of Medicine (NLM) to publish up-to-date and accurate drug labels (also called a "package insert") to health care providers and the general public. The contents of DailyMed is provided and updated daily by the U.S. Food and Drug Administration (FDA). The FDA in turn collects this ...
The advisers essentially backed the conclusions of an FDA scientific review published ahead of this week’s meeting, which found numerous flaws in the 1960s and 1970s studies that supported ...
An Alzheimer’s disease drug may soon have a new dosing schedule. The medication, Leqembi, is currently administered via an infusion every two weeks. Under the proposed changes, the medication ...
Xanomeline was licensed to Karuna Therapeutics in 2012 and KarXT was subsequently created as a dual drug formulation by adding trospium. Trospium is a non-brain-penetrant and non-selective muscarinic receptor blocker that may ameliorate the peripheral side effects of xanomeline.
The US Food and Drug Administration (FDA) approved Lifileucel through the accelerated approval pathway and granted the application orphan drug, regenerative medicine advanced therapy, fast track, and priority review designations under the brand name Amtagvi to Iovance Biotherapeutics.
Varenicline received a priority review by the US FDA in February 2006, shortening the usual ten-month review period to six months because of its demonstrated effectiveness in clinical trials and perceived lack of safety issues. [47] The agency's approval of the drug came in May 2006.
By gaining approval for a drug that treats a neglected disease, J&J is now able to request expedited FDA review of a future drug. [25] When it was approved by the FDA in December 2012, it was the first new medicine for TB in more than 40 years. [26] [27] In 2016, the WHO came under criticism for recommending it as an essential medicine. [28]
Despite a higher incidence of breast cancer amongst those taking orlistat in early, pooled clinical trial data—the analysis of which delayed FDA review of orlistat [24] —a two-year study published in 1999 found similar rates between orlistat and placebo (0.54% versus 0.51%), and evidence that tumors predated treatment in 3 of the 4 ...