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EMA/FDA

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…

EMA provides public access to clinical reports

Opening up clinical data on new medicines As of today (October 20), the European Medicines Agency (EMA) gives open access to clinical reports for new medicines for human use authorised…

Gilead asks FDA to expand exclusivity for a key HIV drug

In the latest development in a heated battle between Gilead Sciences and the US Food and Drug Administration, the company petitioned the agency this month to retroactively grant five years…

First comprehensive overview of global initiatives on medicine regulation published

Mapping aims to improve international collaboration The European Medicines Agency (EMA) has published today an overview of existing international regulatory initiatives for human medicines. The mapping was carried out by…

FDA, EMA officials: Regulators must adapt to effectively regulate precision medicine

In order to effectively regulate precision medicine, regulators must adapt to alternative methods of evidence generation, say top officials at the US Food and Drug Administration (FDA) and European Medicines…

CHMP recommends for approval generic versions of Truvada and Viread

At its October meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended for approval two generic versions of Truvada – Emtricitabine/Tenofovir disoproxil Mylan (emtricitabine/tenofovir disoproxil)…