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EMA/FDA

FDA updates hepatitis C drug labeling to include new clinical data

The FDA has approved updates to the labeling for hepatitis C virus (HCV) drug glecaprevir and pibrentasvir (Mavyret) to include new data from 2 clinical studies, according to a press…

Theratechnologies press releases: Trogarzo

European Medicines Agency confirms accelerated assessment procedure for Trogarzo™ The Committee for Medicinal Products for Human Use of the European Medicines Agency will review the application for marketing authorization of…

Brexit preparedness: EMA to further temporarily scale back and suspend activities

Next phase of business continuity plan aimed at securing essential public and animal health activities The European Medicines Agency (EMA) will launch the next phase of its business continuity plan…

FDA: Intelence indication expanded to include younger HIV patients

The Food and Drug Administration (FDA) has approved updated labeling for Intelence (etravirine; Janssen) to include treatment-experienced pediatric patients 2 to <6 years of age weighing ≥10kg for the treatment…

EMA: EU and Japan reinforce their collaboration on inspections of medicine manufacturers

Update of 2004 mutual recognition agreement extends scope to sterile products, active pharmaceutical ingredients and biologicals including vaccines The European Union (EU) and Japan have agreed to broaden the range…

FDA approves SYMTUZA

Janssen announces U.S. FDA approval of SYMTUZA (D/C/F/TAF), the first and only complete darunavir-based single-tablet regimen for the treatment of HIV-1 infection Read the press release here.

EMA’s proactive publication of clinical data a success

First report on unprecedented transparency policy shows high user satisfaction The European Medicines Agency (EMA) has published the first report on the implementation of its flagship policy on the publication…

EMA identifies gaps in industry preparedness for Brexit

Survey indicates that some companies need to step up efforts to ensure medicine supply in the EU A recent European Medicines Agency (EMA) survey shows that marketing authorisation holders for…

European Commission grants Marketing Authorization for Biktarvy

European Commission grants Marketing Authorization for Gilead’s Biktarvy® (bictegravir, emtricitabine, tenofovir alafenamide) for the treatment of HIV-1 infection – In clinical trials, Biktarvy demonstrated high efficacy and zero resistance through…

EMA: Guidance for pharmaceutical companies to prepare for UK’s withdrawal from EU

Publication of updated Q+As and practical guidance The European Medicines Agency (EMA) and the European Commission have updated their guidance to help pharmaceutical companies prepare for the United Kingdom’s (UK)…

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