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EMA/FDA

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…

FDA approves first two-drug regimen for certain patients with HIV

The U.S. Food and Drug Administration today approved Juluca, the first complete treatment regimen containing only two drugs to treat certain adults with human immunodeficiency virus type 1 (HIV-1) instead…

Theratechnologies announces FDA decision to extend the ibalizumab review period

Theratechnologies Inc. announced that it was notified by its partner, TaiMed Biologics, Inc., that the U.S. Food and Drug Administration will extend its review of the Biologics License Application for…

FDA approves hepatitis C drugs label updates

FDA recently approved changes to the labels of: Sovaldi (sofosbuvir), Harvoni (ledipasvir and sofosbuvir), Epclusa (sofosbuvir and velpatasvir) and Vosevi (sofosbuvir, velpatasvir, and voxilaprevir). The approved changes are detailed here.…

Dynavax announces FDA approval of HEPLISAV-B(TM) for prevention of hepatitis B in adults

First and only two-dose vaccine in United States for prevention of hepatitis B in adults First new hepatitis B vaccine in United States in more than 25 years BERKELEY, CA…