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BioWorld - Saturday, July 25, 2026
Home » Topics » Regulatory » EMA

EMA
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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

EMEA recommends that new warnings be included in product information for Novartis' Sebivo

Feb. 19, 2008

Lenalidomide approved in Australia and Canada, receives negative opinion in Europe

Jan. 29, 2008

EMEA issues opinion on safety of Gardasil

Jan. 29, 2008
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