Home » Topics » Regulatory » EMA

EMA
RSS

EMA supports E.U. orphan drug designation for Aduro Biotech's CRS-207 and GVAX pancreas

Dec. 16, 2015

EMA accepts MAA for Gedeon Richter's biosimilar pegfilgrastim

Dec. 10, 2015

EMA accepts MAA for Sandoz's etanercept biosimilar

Dec. 9, 2015

EMA validates Gilead's MAA for fixed-dose sofosbuvir/velpatasvir

Dec. 7, 2015

EMA accepts Helsinn's MAA for anamorelin in cancer-related cachexia

Nov. 30, 2015

Zutectra receives positive CHMP opinion for use after liver transplantation

Nov. 25, 2015

AGTC's achromatopsia gene therapies granted orphan drug designations

Nov. 25, 2015

CHMP recommends approval of Episalvan to treat partial thickness wounds in adults

Nov. 24, 2015

CHMP recommends approval of Briviact

Nov. 24, 2015

EMA committee recommends European approval of Wakix for narcolepsy

Nov. 23, 2015

Popular Stories

Today's news in brief
BioWorld
BioWorld briefs for April 2, 2026.
Small-molecule TREM2 agonist advances to treat Alzheimer’s
BioWorld Science
Microglia play a central role in the neuroinflammation associated with Alzheimer’s disease (AD). These cells act as the brain’s immune system and respond to...
Amlogenyx’s AM-805 reduces amyloid plaques in AD
BioWorld Science
The potent carboxypeptidase enzyme protective protein cathepsin A (PPCA) is known to cleave the C-terminus of amyloid-β42, responsible for aggregation and...
News in brief
BioWorld Asia
BioWorld Asia briefs for March 31, 2026
Atai Therapeutics patents new 5-HT2 receptor agonists
BioWorld Science
Atai Therapeutics Inc. has identified new 5-HT2 receptor agonists potentially useful for the treatment of psychiatric disorders.