Home » Topics » Regulatory » EMA

EMA
RSS

Pharming submits response to CHMP for Rhucin MAA for hereditary angioedema

March 19, 2010

Cangene receives European approval for ImmunoGam hepatitis B product

March 18, 2010

Novartis receives E.U. approval for meningococcal Menveo vaccine

March 18, 2010

FDA and EMA grant orphan drug status to ImmunoGen's IMGN-901 in MCC

March 9, 2010

EMA accepts voclosporin for regulatory review

March 3, 2010

Ariad's AP-24534 receives orphan drug status for CML

March 2, 2010

COMP grants perifosine positive opinion as orphan medicinal product in MM

March 2, 2010

EMA approves OncoGenex's development plan for OGX-011

Feb. 26, 2010

Rare Disease Day 2010 focuses attention on orphan drug development

Feb. 26, 2010

CHMP adopts positive opinion on marketing of GSK's pandemic influenza vaccine Arepanrix

Jan. 28, 2010

Popular Stories

Today's news in brief
BioWorld
BioWorld briefs for Dec. 31, 2025.
Today's news in brief
BioWorld MedTech
BioWorld MedTech briefs for Dec. 31, 2025.
Researchers discover how glioblastoma tumors dodge chemotherapy
BioWorld MedTech
Researchers at the University of Sydney have uncovered a mechanism that may explain why glioblastoma returns after treatment, and the world-first discovery offers...
Shionogi nabs revenue-generating ALS drugs with $2.5B Tanabe pact
BioWorld
Shionogi & Co. Ltd. will acquire global rights to U.S. FDA approved amyotrophic lateral sclerosis therapy edaravone through a $2.5 billion acquisition deal with...
Big pharma taps fast Asia innovation in search of next Keytruda
BioWorld
Speed and innovation from Asia Pacific’s (APAC) biotechnology sector had big pharma scouring the region for the next oncology heir to Keytruda (pembrolizumab),...