Home » Topics » Regulatory » EMA

EMA
RSS

EMA validates ledipasvir/sofosbuvir MAA and grants accelerated assessment

March 28, 2014

Siltuximab receives positive CHMP opinion supporting approval in multicentric Castleman's disease

March 25, 2014

CHMP recommends approval of empagliflozin for type 2 diabetes

March 25, 2014

Takeda Pharmaceutical receives positive CHMP opinion for Entyvio

March 25, 2014

EMA committee recommends approval of Vynfinit and companion imaging agents

March 24, 2014

CHMP issues positive opinion for simeprevir in chronic HCV infection

March 24, 2014

European CHMP recommends approval of tablet formulation of Noxafil

March 3, 2014

EMA accepts MAA filing for oritavancin

Feb. 28, 2014

EMA accepts tedizolid phosphate MAA for review

Feb. 28, 2014

Orexigen Therapeutics receives European CHMP questions on NB-32 MAA

Feb. 27, 2014

Popular Stories

Today's news in brief
BioWorld
BioWorld briefs for May 8, 2026.
News in brief
BioWorld Asia
BioWorld Asia briefs for May 5, 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...
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...
Cytospire raises £61M series A to target EGFR in solid tumors
BioWorld
Next-generation T-cell engager (TCE) specialist Cytospire Therapeutics Ltd. has raised £61 million (US$82.7 million) in a series A round, equipping it to advance...