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EMA/FDA

FDA tentatively approves fixed-dose HIV combo therapy

The US Food and Drug Administration (FDA), under the US President's Emergency Plan for AIDS Relief (PEPFAR), has granted tentative approval of a New Drug Application (NDA) for a once-daily,…

FDA approves Gilead’s Biktarvy® for treatment of HIV

U.S. Food and Drug Administration approves Gilead’s Biktarvy® (bictegravir, emtricitabine, tenofovir alafenamide) for treatment of HIV-1 infection In clinical trials, Biktarvy demonstrated high efficacy, few interactions with other drugs and…

FDA: Edurant dosing recommendations updated for pregnant HIV patients

The prescribing information for Edurant (rilpivirine; Janssen) has been updated to include dosing recommendations for pregnant women who are already on a stable Edurant regimen prior to getting pregnant and who…

FDA approves changes to the labels of Prezista and Prezcobix

FDA recently approved changes to the labels of Prezista and Prezcobix. The approved changes are detailed here (for Prezista) and here (for Prezcobix).

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…