Home » Topics » Regulatory » EMA

EMA
RSS

Chiesi's triple combination for the treatment of COPD receives positive opinion from EMA

May 22, 2017

EMA accepts for review MAA for adalimumab biosimilar, FKB-327

May 22, 2017

EMA committee backs approval of Zykadia for first-line use in ALK+ NSCLC

May 22, 2017

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

Popular Stories

Today's news in brief
BioWorld
BioWorld briefs for Feb. 12, 2025.
SCAN is core circuit affected in Parkinson’s disease
BioWorld Science
Parkinson’s disease (PD) is a neurodegenerative disorder that affects movement, and tremor is one of its signatures. But it is a much more wide-ranging disorder,...
Astellas’ ASP-2246 shows promise in stroke management
BioWorld Science
Astellas Pharma Inc. recently presented data regarding ASP-2246, a drug candidate comprised of an mRNA encoding the transcription factor NeuroD1 encapsulated in...
TL1A is overexpressed in hidradenitis suppurativa
BioWorld Science
Despite the availability of advanced therapeutic options, about 40%-50% of patients with hidradenitis suppurativa do not achieve significant improvement in...
News in brief
BioWorld Asia
BioWorld Asia briefs for Feb. 10, 2026