EATG » EMA/FDA

EMA/FDA

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)…

FDA says Prezcobix should not be given to pregnant women

Darunavir/cobicistat — marketed as Prezcobix (Janssen) in the United States — should not be given to pregnant women with HIV because of substantially lower exposures of the two medications during…

Two more EU Member States benefit from EU-US mutual recognition agreement for inspections

Agreement now operational between 14 EU Member States and FDA The mutual recognition agreement between the European Union (EU) and the United States (US) to recognise inspections of manufacturing sites for human medicines conducted…

FDA approves the first non-opioid treatment for management of opioid withdrawal symptoms in adults

Encouraging more widespread innovation and development of safe and effective treatments for opioid use disorder remains top agency priority The U.S. Food and Drug Administration today (May 16) approved Lucemyra…

Juluca receives EU marketing authorisation

-- ViiV Healthcare's press release: ViiV Healthcare receives EU marketing authorisation for Juluca (dolutegravir/rilpivirine), the first 2-drug regimen, once-daily, single-pill for the treatment of HIV -- Janssen's press release: Janssen…