Home » Topics » Regulatory » EMA

EMA
RSS

Novartis' dual bronchodilator QVA-149 recommended for approval in COPD by CHMP

July 29, 2013

EMA issues negative opinion on delamanid for tuberculosis

July 29, 2013

EMA committee recommends approval of Revolade expanded indication

July 29, 2013

EMA's CHMP recommends approval of VEGF Trap-Eye/Eylea for new indication

July 29, 2013

EMA committee recommends Defitelio approval under exceptional circumstances

July 29, 2013

CHMP confirms Xeljanz recommendation

July 26, 2013

FDA and EMA accept Plegridy marketing applications for review

July 22, 2013

EMA grants orphan drug status to OXiGENE's Zybrestat in ovarian cancer

July 19, 2013

EMA committee recommends orphan drug status for Soliris in rare neurological disease

July 19, 2013

Oryzon obtains European orphan drug designation for ORY-1001 in AML

July 17, 2013

Popular Stories

Today's news in brief
BioWorld
BioWorld briefs for May 8, 2026.
First measles treatment advances as vaccination rates drop
BioWorld
Scientists at the La Jolla Institute for Immunology have identified and characterized human antibodies that neutralize the measles virus by blocking its entry...
Infensa Bioscience identifies new ASIC blockers
BioWorld Science
Infensa Bioscience Pty Ltd. has patented new acid-sensing ion channel 1 (ASIC) blockers potentially useful for the treatment of stroke, among others.
Kymera’s IRF5 degrader shows potential in IBD treatment
BioWorld Science
At the recently concluded Digestive Disease Week, researchers from Kymera Therapeutics Inc. presented preclinical efficacy data on KT-579, a selective oral IRF5...
Hantavirus is ‘sentinel’ more than acute pandemic threat
BioWorld
News of eight infections and three deaths so far due to an emerging zoonotic virus has brought back unhappy memories of the early days of SARS-CoV-2. At a press...