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EMA/FDA

Workshop: measuring the impact of pharmacovigilance activities

The event will be web-streamed on 5-6 December The European Medicines Agency (EMA) is organising a workshop to discuss methods to measure the impact of pharmacovigilance activities on patient safety.…

Workshop: towards new treatments for TB

The event will be broadcast on 25 November 2016 The European Medicines Agency (EMA) is organising a workshop on the development of new medicines to treat tuberculosis (TB). The event…

EMA: Revising the guideline on first-in-human clinical trials

Changes are open for comments until end of February 2017 The European Medicines Agency (EMA), in cooperation with the European Commission and the Member States of the European Union (EU),…

Dynavax says FDA rejects its hepatitis B vaccine

The U.S. Food and Drug Administration rejected Dynavax Technologies Corp's marketing application for its hepatitis B vaccine, Heplisav-B, for the second time in three years, sending the company's shares tumbling…

CHMP adopts positive opinion for Vemlidy for the treatment of hepatitis B

European CHMP adopts positive opinion for Gilead’s Vemlidy® (tenofovir alafenamide, TAF) for the treatment of chronic hepatitis B virus infection Vemlidy demonstrated similar efficacy with improvements in renal and bone…

Brochure: The European regulatory system for medicines

The European Medicines Agency developed a brochure on the European regulatory system for medicines. The booklet explains how the European regulatory system for medicines operates. It describes how medicines are authorized…

CHMP recommends for approval generic version of Prezista

At its November meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended for approval a generic version of Prezista – Darunavir Mylan (darunavir) for the treatment…

FDA approves Vemlidy for the treatment of hepatitis B

U.S. Food and Drug Administration approves Gilead’s Vemlidy® (tenofovir alafenamide) for the treatment of chronic hepatitis B virus infection Vemlidy is a once-daily treatment that demonstrated similar efficacy with improved…

FDA: Selzentry approved for pediatric use

On Friday November 4, 2016, FDA approved Selzentry (maraviroc) 20 mg/mL oral solution, Selzentry (maraviroc) 25 mg and 75 mg tablets and updated the label to include use in pediatric…

Arrowhead provides update on Heparc-2004 study

PASADENA, Calif., Nov 8, 2016 -- Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) is providing an update on its Heparc-2004 clinical study of ARC-520, its therapeutic candidate under clinical investigation for the…