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The FDA’s plan to require more stability data for ANDAs is likely to slow approvals unless the agency flexes a little, generic-drug makers say.
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Manufacturers of transdermal patches should minimize the amount of residual drug substance in the patch as much as possible to avoid patient and environmental safety risks, according to a new European Medicines Agency (EMA) draft guideline.
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The FDA has revised and clarified a final ICH question-and-answer guidance on the evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs.
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Bayer reported positive data from an ongoing Phase III Patent-1 study evaluating the oral guanylate cyclase (sGC) stimulator riociguat (BAY 63-2521) as a treatment for pulmonary arterial hypertension (PAH) in treatment-naïve patients and those who have previously received an endothelin receptor antagonist or prostanoid therapy.
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Sanofi Pasteur, the vaccines division of Sanofi, presented an overview of Phase II and Phase III clinical trials for its investigational quadrivalent influenza vaccine.
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Vivus’ obesity drug, approved in July in the U.S., failed to gain the backing of European drug regulators because of its potential side effects.
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A U.S. Department of Health and Human Services office has rejected an industry proposal to use government bonds to fund the development of drugs countering bioterrorism threats.
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The majority of drugs used in the pediatric intensive care unit are used in an off-label manner, exposing patients to medications that may not have been adequately studied in children, according to a single-center study.
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Pfizer announced its intention to acquire NextWave Pharmaceuticals, a privately held, specialty pharmaceutical company focused on the development and commercialization of unique products for the treatment of attention deficit/hyperactivity disorder and related central nervous system disorders.
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