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EMA/FDA

Merck receives CHMP positive opinion recommending approval of ISENTRESS® 600 mg in Europe

KENILWORTH, N.J., May 19, 2017 - Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a…

CHMP recommends for approval generic version of Atripla

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

New safety concerns identified for 1 in 3 FDA-approved drugs

Nearly one out of every three drugs approved by the Food and Drug Administration (FDA) have a new safety issue detected in the years after approval, says a Yale-led study.…

EMA launches second communication perception survey

Communication@EMA – how are we doing? The European Medicines Agency (EMA) has launched its bi-annual communication perception survey. The purpose of the survey is to gather feedback from all EMA…

EMA 2016 annual report published

Progress on science, medicines and health The European Medicines Agency’s (EMA) 2016 annual report published today focuses on the Agency’s key achievements in the areas of medicine evaluation, support to…

Scott Gottlieb wins confirmation as FDA commissioner

Dr. Scott Gottlieb is headed back to the Food and Drug Administration. By a vote of 57 to 42, the Senate on Tuesday confirmed Gottlieb, a former FDA deputy commissioner, as…

EMA: Involving patients in discussions on benefits and risks of medicines

EMA publishes report on CHMP pilot project The European Medicines Agency (EMA) has published a final report on the experience gained during its pilot project to involve patients directly in…

EMA communication perception survey 2017

The European Medicines Agency (EMA) is carrying out a survey to assess how its communications to the general public are perceived and valued by the stakeholders. This will provide valuable…

Theratechnologies partner submits Biologics License Application to FDA for ibalizumab

Theratechnologies partner submits Biologics License Application for HIV monoclonal antibody and long-acting investigational antiretroviral ibalizumab MONTREAL, QUEBEC, May 3, 2017 - Theratechnologies Inc. (Theratechnologies) today announced that its partner, TaiMed…

FDA: STRIBILD and TYBOST labels updated

The STRIBILD and TYBOST labels were updated to include revised text regarding corticosteroids. The changes are outlined here.