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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2020

Eleven new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended eleven medicines for approval at its July 2020 meeting, including a medicine for use in countries outside the European Union. The CHMP adopted a positive opinion for Dapivirine Vaginal Ring (dapivirine) used to reduce the risk of infection with the human immunodeficiency virus […]

First antibody-drug conjugate for multiple myeloma patients with limited treatment options

EMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorisation in the European Union for Blenrep (belantamab mafodotin) to treat adult patients with relapsed and refractory multiple myeloma who no longer respond to treatment with an immunomodulatory agent, a proteasome inhibitor and a CD-38 monoclonal antibody. Multiple myeloma is a cancer of a […]

Vaginal ring to reduce the risk of HIV infection for women in non-EU countries with high disease burden

EMA’s human medicines committee (CHMP) has adopted a positive opinion for Dapivirine Vaginal Ring (dapivirine) used to reduce the risk of infection with the human immunodeficiency virus type 1 (HIV-1), in combination with safer sex practices when oral pre-exposure prophylaxis (PrEP) is not used, cannot be used or is not available. Placed in the vagina, […]

EMA starts review of dexamethasone for treating adults with COVID-19 requiring respiratory support

EMA is reviewing results from the RECOVERY study arm that involved the use of dexamethasone in the treatment of patients with COVID-19 admitted to hospital. This part of the study looked into the effects of adding dexamethasone to usual care in adults receiving invasive ventilation, those given oxygen (e.g. through a mask) or those receiving no […]