Home » Topics » Regulatory » EMA

EMA
RSS

PTC Therapeutics offers U.S. and E.U. regulatory update on Translarna

Oct. 18, 2016

Positive opinion handed down in E.U. for SomaKit TOC

Oct. 18, 2016

EMA gives orphan drug designation to Eiger's exendin 9-39

Oct. 18, 2016

AbbVie receives positive opinion for Venclyxto tablets in patients with difficult-to-treat CLL

Oct. 17, 2016

Bristol-Myers Squibb receives positive CHMP opinion for nivolumab

Oct. 17, 2016

EMA committee recommends approval of Rekovelle

Oct. 17, 2016

Obeticholic acid granted positive CHMP opinion as treatment of primary biliary cholangitis

Oct. 17, 2016

Full results from European phase III study of Infacort in pediatric adrenal insufficiency

Oct. 13, 2016

EMA issues positive opinion on Atara Biotherapeutics' CMVpp65-CTL

Oct. 13, 2016

EMA grants orphan drug designation to Videregen's replacement trachea product

Oct. 7, 2016

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...
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.