Home » Topics » Regulatory » EMA

EMA
RSS

EMA validates application seeking expanded approval of Sprycel

May 22, 2017

CHMP recommends approval of Insulin lispro Sanofi

May 22, 2017

EMA committee hands down positive opinion on Veltassa for treatment of hyperkalemia

May 19, 2017

CHMP adopts negative opinion for masitinib in indolent systemic mastocytosis

May 19, 2017

Apellis Pharmaceuticals granted E.U. orphan drug designation for APL-2 in PNH

May 10, 2017

EMA grants PRIME designation to AMT-060 in hemophilia B

April 26, 2017

EMA committee recommends approval of Skilarence for psoriasis

April 25, 2017

EMA committee adopts positive opinion on Opdivo in locally advanced or metastatic urothelial cancer

April 24, 2017

EMA committee recommends E.U. approval of Kevzara

April 24, 2017

Sandoz rituximab and etanercept biosimilars recommended for approval in E.U.

April 24, 2017

Popular Stories

Today's news in brief
BioWorld
BioWorld briefs for July 23, 2026.
To viral or not to viral: In vivo CAR T debates delivery tech
BioWorld
The field of cell and gene therapy is moving toward a new phase of scalability and clinical durability, with in vivo chimeric antigen receptor (CAR) T-cell...
News in brief
BioWorld Asia
BioWorld Asia briefs for July 21, 2026
KBN-2201 reverses key features of Alzheimer’s in mice
BioWorld Science
Researchers from Ajou University School of Medicine reported the preclinical efficacy of KBN-2201 in a mouse model of late-stage Alzheimer’s disease.
In vivo click ADCs could address tumor heterogeneity
BioWorld
Researchers at Washington University in St. Louis have used click chemistry to link a second antibody to a pre-existing antibody-drug conjugate (ADC) in vivo. In...