Home » Topics » Regulatory » EMA

EMA
RSS

Positive CHMP opinion on new indications for Xarelto

Sep. 27, 2011

Gilead Sciences announces CHMP's opinion on Eviplera

Sep. 27, 2011

Optimer Pharmaceuticals and Astellas gain CHMP recommendation for Dificid approval

Sep. 26, 2011

Rasitrio recommended for approval in E.U.

Sep. 26, 2011

CHMP issues opinion on Edarbi for essential hypertension

Sep. 26, 2011

EMA begins review of orlistat-containing antiobesity medicines

Sep. 26, 2011

EMA confirms positive benefit-to-risk balance for Multaq

Sep. 23, 2011

EMA committee recommends extending approval of Levemir

Sep. 23, 2011

Mesoblast clear to initiate phase II trial of Revascor

Sep. 5, 2011

EP-217609 obtains European orphan drug status

Aug. 24, 2011

Popular Stories

Today's news in brief
BioWorld
BioWorld briefs for Dec. 31, 2025.
Today's news in brief
BioWorld MedTech
BioWorld MedTech briefs for Dec. 30, 2025.
Researchers discover how glioblastoma tumors dodge chemotherapy
BioWorld MedTech
Researchers at the University of Sydney have uncovered a mechanism that may explain why glioblastoma returns after treatment, and the world-first discovery offers...
Shionogi nabs revenue-generating ALS drugs with $2.5B Tanabe pact
BioWorld
Shionogi & Co. Ltd. will acquire global rights to U.S. FDA approved amyotrophic lateral sclerosis therapy edaravone through a $2.5 billion acquisition deal with...
Big pharma taps fast Asia innovation in search of next Keytruda
BioWorld
Speed and innovation from Asia Pacific’s (APAC) biotechnology sector had big pharma scouring the region for the next oncology heir to Keytruda (pembrolizumab),...