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BioWorld - Saturday, February 14, 2026
Home » Topics » Regulatory » EMA

EMA
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EMA's CHMP recommends label extension for tocilizumab

May 24, 2011

EMA committee recommends accelerated approval of Victrelis for hepatitis C genotype 1

May 23, 2011

CHMP recommends approval of Vibativ for nosocomial pneumonia caused by MRSA

May 23, 2011

GSK and Human Genome Sciences receive CHMP positive opinion for Benlysta

May 23, 2011

CHMP recommends conditional marketing authorization of Fampyra

May 23, 2011

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
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