Home » Topics » Regulatory » EMA

EMA
RSS

EMA acknowledges that Clinuvel's proposed dossier for afamelanotide meets all filing requirements

May 12, 2011

EMA agrees to pediatric investigational plan for rFIXFc in hemophilia B

May 9, 2011

EMA provides Keryx Biopharma with scientific advice on Zerenex in hyperphosphatemia

May 3, 2011

Clinuvel and EMA to meet regarding proposed MAA for Scenesse in EPP

April 26, 2011

Novartis withdraws MAA for Joicela in osteoarthritis

April 20, 2011

CHMP recommends amendments to Pandemrix's product information

April 19, 2011

CHMP recommends approval of dabigatran etexilate for prevention of stroke in patients with AF

April 18, 2011

CHMP recommends approval of once-weekly exenatide for type 2 diabetes

April 18, 2011

CHMP adopts positive opinion on Avastin/Xeloda combination in metastatic breast cancer

April 18, 2011

Delcath receives CE mark for Hepatic Chemosat delivery system

April 18, 2011

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),...