Home » Topics » Regulatory » EMA

EMA
RSS

Janssen-Cilag notifies EMEA of withdrawal of Comfyde MAA for partial-onset seizures

Jan. 26, 2010

EMEA recommends withdrawal of benfluorex from the market in E.U.

Dec. 28, 2009

Bayer Schering withdraws European MAA for Recothrom (thrombin alfa)

Dec. 16, 2009

GSK withdraws centralized MAA for Zunrisa in postoperative nausea and vomiting

Oct. 16, 2009

CHMP issues positive opinion for Baxter's Celvapan H1N1 pandemic influenza vaccine

Oct. 6, 2009

E.C. approves Novartis' Focetria vaccine for use in the H1N1 influenza pandemic

Oct. 1, 2009

EMEA withdraws marketing authorization for Posaconazole SP

Aug. 7, 2009

GlaxoSmithKline withdraws MAA for Bosatria

Aug. 3, 2009

European CHMP recommends marketing authorization for Tigenix's ChondroCelect

July 2, 2009

CHMP adopts positive opinion for Otsuka's Samsca in hyponatremia

June 12, 2009

Popular Stories

Today's news in brief
BioWorld
BioWorld briefs for Dec. 17, 2025.
Today's news in brief
BioWorld MedTech
BioWorld MedTech briefs for Dec. 17, 2025.
CTAD 2025: Diagnosing semaglutide’s failure in Alzheimer’s trials
BioWorld
A little over a week after announcing that the Evoke and Evoke+ studies failed to show that oral semaglutide could slow cognition decline in patients with...
European Commission floats multiple fixes for MDR, IVDR
BioWorld MedTech
The European Union’s struggles with regulations for devices and in vitro diagnostics seem virtually endless, but the European Commission floated a series of...
Apollo’s APL-4098 shows potent antileukemic effects
BioWorld Science
Apollo Therapeutics Ltd. has developed APL-4098, a small-molecule general control nonderepressible 2 (GCN2) inhibitor for the potential treatment of AML.