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BioWorld - Thursday, May 28, 2026
Home » Topics » Regulatory » EMA

EMA
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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

CHMP recommends suspension of marketing authorization for sibutramine

Jan. 26, 2010

EMEA recommends additional measures to manage risk for PML with Tysabri therapy

Jan. 26, 2010

Janssen-Cilag notifies EMEA of withdrawal of Comfyde MAA for partial-onset seizures

Jan. 26, 2010
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