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BioWorld - Friday, January 9, 2026
Home » Topics » Regulatory » EMA

EMA
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EP-217609 obtains European orphan drug status

Aug. 24, 2011

Cres Pharmaceuticals compound obtains orphan status for primary myelofibrosis

Aug. 23, 2011

Cell Therapeutics submits response to questions raised by EMA regarding pixantrone MAA

Aug. 23, 2011

Fresolimumab receives orphan drug designation in the E.U.

Aug. 23, 2011

EMA accepts for review submissions by Pfizer for two investigational anticancer therapies

Aug. 22, 2011

MAA accepted and NDA submitted for ridaforolimus

Aug. 19, 2011

EMA provides scientific advice regarding phase III trial of CPP-1X in FAP

Aug. 3, 2011

EMA accepts Eisai's application to extend use of zonisamide

July 28, 2011

Interim phase II data presented on combination regimen including VX-222 in chronic hepatitis C

July 28, 2011

EMA accepts for review Vanda's MAA for oral iloperidone formulation

July 27, 2011
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