April 30, 2014 – The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for Mekinist (trametinib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E mutation. Mekinist …

European Medicines Agency (EMA) recommends approval of Trametinib [Mekinist] for the treatment of melanoma with a BRAF V600E mutation Read more »

April 09, 2104 – Usually, we talk and present here issues on health and disease, therapies notwithstanding which are based on the genetic background (i.e. predisposition) of the individual.  Another aspect of predisposition for dieseas is of course the situation …

World Tuberculosis Day: Three new medicines recommended by EMA in last six months for patients with multidrug-resistant tuberculosis Read more »

March 21, 2014 – The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation for Vynfinit (vintafolide) for the treatment of women with a subtype of platinum-resistant ovarian cancer for which there …

EMA recommends approval of Vintafolide [Vynfinit] as a new treatment for platinum-resistant ovarian cancer together with companion diagnostic. Read more »

On 20 March 2014, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Sylvant, 100 mg and 400 mg, Powder for concentrate for solution for …

EMA: Granting of a marketing authorisation for the medicinal product Siltuximab [Sylvant] for the treatment of multicentric Castleman’s Disease (MCD) recommended. Read more »

May 09, 2013 – This is from the News and Press Release Archive of the European Medicines Agency (EMA) as of April 29, 2013.  Find here the unedited release in full: 29/04/2013 Recommendation to suspend tetrazepam-containing medicines endorsed by CMDh …

EMA: Recommendation to suspend tetrazepam-containing medicines Read more »

January 17, 2012 – Recently, the European Medicines Agency (EMA) has announced that it  is reviewing aliskiren-containing medicines, to assess the impact of data coming from the ALTITUDE study on the balance of benefits and risks of these medicines in their approved indication. Aliskiren-containing …

European Medicines Agency (EMA) starts review of aliskiren-containing medicines Read more »