Home » Topics » Regulatory » EMA

EMA
RSS

CHMP issues positive opinion for Translarna for nonsense mutation DMD

May 26, 2014

TxCell's Col-Treg receives Advanced Therapy Medicinal Product designation

May 26, 2014

CHMP issues positive opinion for Envarsus in kidney and liver transplant patients

May 23, 2014

MOR-208 receives FDA and EMA orphan drug designations

May 21, 2014

Afamelanotide gains FDA and EMA orphan status for benign familial pemphigus

May 20, 2014

Anoro Ellipta approved in E.U. for COPD

May 9, 2014

C-Cure receives EMA certification of quality data

May 8, 2014

CHMP recommends variation to marketing authorization of Invega

April 29, 2014

EMA committee recommends approval of Mekinist

April 28, 2014

Boehringer Ingelheim's antithrombotic receives positive opinion from the EMA

April 28, 2014

Popular Stories

Today's news in brief
BioWorld
BioWorld briefs for March 16, 2026.
Precision psychiatry beyond, or before, biomarkers
BioWorld
There is broad agreement that psychiatric diagnoses in their current form are not reflective of any underlying biology, and that this is one of the things...
Keros reports beneficial effects of RKER-065 in ALS model
BioWorld Science
Keros Therapeutics Inc. has presented data regarding their activin receptor ligand trap, RKER-065, for the inhibition of the activin/myostatin signaling axis.
News in brief
BioWorld Asia
BioWorld Asia briefs for March 10, 2026
First-in-class POLG activator restores mtDNA across mutations
BioWorld Science
Researchers from Pretzel Therapeutics Inc. presented preclinical data of PX-578, a first-in-class POLG activator aimed at restoring mtDNA replication and...