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EMA/FDA

Highlights from the European Medicines Agency

The European Medicines Agency has published three video animations to explain how it ensures that medicines are effective and safe for the benefit of patients across the European Economic Area.…

Juluca labeling updated to correct dosing separation information

The Food and Drug Administration (FDA) has approved an update to the labeling for Juluca (dolutegrair/rilpivirine; Janssen) to correct dosing separation between Juluca and oral calcium and iron supplements. The…

Merck submits New Drug Applications for doravirine to FDA

FDA accepts New Drug Applications for Merck’s doravirine, the company’s investigational non-nucleoside reverse transcriptase inhibitor (NNRTI), for treatment of HIV-1 infection KENILWORTH, N.J., January 8, 2018 - Merck (NYSE:MRK), known…

EMA to occupy temporary facility until new HQ is ready

The Europeans Medicines Agency, which is relocating to Amsterdam following Brexit, said its new headquarters will not be ready until November 2019 and until then will occupy space provided temporarily…

Highlights from the CHMP December meeting

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

FDA approves ISENTRESS for the treatment of HIV in newborns

Merck receives FDA approval for ISENTRESS® (raltegravir), in combination with other antiretroviral agents, for the treatment of HIV-1 infection in newborns weighing at least 2 kg Only integrase inhibitor approved…

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

EMA and European Commission publish updated Q&As The European Medicines Agency (EMA) and the European Commission have published additional guidance to help pharmaceutical companies prepare for the United Kingdom’s withdrawal…

EMA: Guidance to help pharma companies prepare for Brexit

Additional guidance relates to medicines for human and veterinary use The European Medicines Agency (EMA) has published additional guidance to help pharmaceutical companies prepare for the United Kingdom’s (UK) withdrawal…

FDA expands Isentress indication for HIV-1 exposed full-term newborns

The FDA has approved expanded indication of Isentress to include HIV-1 exposed full-term neonates, from birth to 4 weeks of age. Isentress (raltegravir, Merck) is now indicated in combination with…

EMA to relocate to Amsterdam, the Netherlands

Agency to begin working immediately with Dutch government to ensure successful move by end of March 2019 The European Medicines Agency (EMA) will relocate to Amsterdam in the Netherlands. This…

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