Home » Topics » Regulatory » EMA

EMA
RSS

CF-102 receives EMA orphan drug designation for HCC

Oct. 13, 2015

Akebia reaches agreement with FDA and EMA on phase III program for vadadustat

Oct. 7, 2015

EMA accepts Ultragenyx's MAA for aceneuramic acid prolonged release

Oct. 5, 2015

PTC Therapeutics submits variation for new indication in Europe for Translarna

Oct. 1, 2015

EMA committee recommends approval of Numient for Parkinson's disease

Sep. 29, 2015

European committee recommends approval of aflibercept for myopic CNV

Sep. 28, 2015

Amgen's Kyprolis and Blincyto receive positive opinions from EMA's CHMP

Sep. 28, 2015

EMA committee hands down positive opinion for Ravicti

Sep. 28, 2015

Exelixis' cobimetinib receives positive opinion from CHMP for treatment of melanoma

Sep. 28, 2015

CHMP adopts positive opinion on Gilead's Genvoya for HIV infection

Sep. 28, 2015

Popular Stories

Today's news in brief
BioWorld
BioWorld briefs for June 18, 2026.
News in brief
BioWorld Asia
BioWorld Asia briefs for June 16, 2026
Gene replacement rescues autism-related phenotypes in mice
BioWorld Science
Autism spectrum disorder (ASD), developmental epileptic encephalopathies and other neurodevelopmental disorders are driven by the disruption of genes regulating...
For clonal hematopoiesis, epigenetics can be in driver’s seat
BioWorld Science
Clonal hematopoiesis (CH), where few blood stem cells produce a significant fraction of mature blood cells that are genetically identical, is partly an inevitable...
Elixiron’s enrupatinib shows upbeat interim phase II AD results
BioWorld
Elixiron Immunotherapeutics Inc. announced positive interim open-label phase II Alzheimer’s disease (AD) study findings of enrupatinib, an oral brain-penetrant...