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EMA/FDA

IPM’s dapivirine vaginal ring now under review by European Medicines Agency

IPM’s application for dapivirine vaginal ring for reducing HIV risk in women now under review by European Medicines Agency Product would offer women at high risk the first long-acting HIV…

EMA validates Gilead’s Marketing Authorization Application for once-daily single tablet HIV regimen

European Medicines Agency validates Gilead’s Marketing Application for fixed-dose combination of bictegravir, emtricitabine and tenofovir alafenamide for treatment of HIV EMA MAA validation follows submission of NDA for BIC/FTC/TAF to…

Post-Brexit EU drug regulation deal urged by ministers

The UK will continue to co-operate with the European Union on medicine testing after it leaves the bloc, two senior ministers have suggested. Business Secretary Greg Clark and Health Secretary…

EMA and EUnetHTA step up interaction to align data requirements

A new joint platform for parallel consultation will provide advice to medicine developers and facilitate access to medicines for patients The European Medicines Agency (EMA) and the European Network for…

FDA grants Priority Review to HIV monoclonal antibody ibalizumab

FDA grants Priority Review to HIV monoclonal antibody and long-acting investigational antiretroviral ibalizumab -- Biologics License Application accepted for review with a target action date of January 3, 2018 --…

EMA: Publication of clinical data survey

The European Medicines Agency (EMA) launched the clinical data website on 20 October 2016 in line with its policy on the publication of clinical data (Policy 0070). To collect the views of the users…

FDA grants Roche premarket approval for fourth-generation HIV combination antigen-antibody assay

The FDA granted Roche premarket approval for its fourth-generation HIV combination antigen-antibody assay, the company announced today (June 23). The Elecsys HIV combi PT assay is intended to be used…

New pan-genotypic hepatitis C drug combinations recommended for approval in the European Union

Two new pan-genotypic direct-acting antiviral combinations have received positive opinions from the scientific committee of the European Medicines Agency and should receive European Union marketing approval in next few months,…

CHMP recommends for approval generic version of Atripla

At its June meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended for approval a generic version of Atripla – Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan (efavirenz/emtricitabine/tenofovir disoproxil)…

EMA Management Board: highlights of June 2017 meeting

Focus on Brexit preparations and the development of the EU clinical trial portal and database Brexit preparations The Management Board of the European Medicines Agency (EMA) was updated on the…