EMA

RSS

Anticoagulant Xarelto recommended for approval in E.U.; NDA submitted in U.S.

July 30, 2008

CHMP recommends refusal of Santhera's MAA for Sovrima in Friedreich's ataxia

July 30, 2008

CHMP adopts negative opinion for Howmedica's Opgenra

July 4, 2008

EMEA recommends that product information for Pfizer's Exubera include data on lung cancer

June 19, 2008

Novartis withdraws MAA for pre-pandemic vaccine Aflunov

June 18, 2008

CHMP recommends refusing Takeda's MAA for ramelteon

June 9, 2008

Positive opinion issued to broaden use of Erbitux, including first-line colorectal cancer

June 9, 2008

CHMP issues positive opinion for antibacterial agent Doribax

June 6, 2008

CHMP issues positive opinion for icatibant in HAE; FDA issues not approvable letter

April 28, 2008

GSK receives CHMP positive opinion for Volibris

Feb. 25, 2008