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EMA/FDA

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…

EMA: Webinar on regulatory and procedural aspects of applications for type I variations

EMA provides guidance to improve quality of applications The European Medicines Agency (EMA) is organising a webinar on 15 November 2016 to advise stakeholders on regulatory and procedural aspects of…

EMA: How to make better use of patient registries to collect high-quality data on medicines

Workshop to be broadcast live on 28 October A workshop on patient registries will discuss concrete solutions to better use existing patient registries that collect high-quality data from the use…