FDA approves treatment for chronic graft versus host disease
The U.S. Food and Drug Administration today expanded the approval of Imbruvica (ibrutinib) for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more treatments. This is the first FDA-approved therapy for the treatment of cGVHD.
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FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death
The U.S. Food and Drug Administration today announced a new comprehensive plan for tobacco and nicotine regulation that will serve as a multi-year roadmap to better protect kids and significantly reduce tobacco-related disease and death. The approach places nicotine, and the issue of addiction, at the center of the agency's tobacco regulation efforts.
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FDA approves Vosevi for Hepatitis C
The U.S. Food and Drug Administration has approved Vosevi to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis. Vosevi is a fixed-dose, combination tablet containing two previously approved drugs - sofosbuvir and velpatasvir - and a new drug, voxilaprevir.
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FDA tackles drug competition to improve patient access
Today, the U.S. Food and Drug Administration is taking two new, important steps to increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives. The agency published a list of off-patent, off-exclusivity branded drugs without approved generics, and also implemented, for the first time, a new policy to expedite the review of generic drug applications where competition is limited.
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Statement from FDA Commissioner Scott Gottlieb, M.D., on the importance of the Drug Quality and Security Act and overseeing the safety of compounded drugs
In late 2012, the United States faced the most serious outbreak associated with contaminated compounded drugs in recent history, involving hundreds of people, in many states, who developed fungal infections related to a compounded product. It was an incident that resulted in dozens of deaths.
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FDA approves first generic Strattera for the treatment of ADHD
The U.S. Food and Drug Administration has approved the first generic versions of Strattera (atomoxetine) to treat attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult patients. Apotex Inc., Teva Pharmaceuticals USA Inc., Aurobindo Pharma Limited and Glenmark Pharmaceuticals Limited gained approval to market atomoxetine in multiple strengths.
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Green light given for new EudraVigilance system for collection and monitoring of suspected adverse reactions
The European Medicines Agency (EMA) will launch a new and improved version of EudraVigilance, the European information system of suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the European Economic Area (EEA). The new version of EudraVigilance will go live on 22 November 2017 with enhanced functionalities for reporting and analysing suspected adverse reactions.
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The U.S. Food and Drug Administration today expanded the approval of Imbruvica (ibrutinib) for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more treatments. This is the first FDA-approved therapy for the treatment of cGVHD. 
The European Medicines Agency (EMA) will launch a new and improved version of EudraVigilance, the European information system of suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the European Economic Area (EEA). The new version of EudraVigilance will go live on 22 November 2017 with enhanced functionalities for reporting and analysing suspected adverse reactions.