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BioWorld - Saturday, May 9, 2026
Home » Topics » Regulatory » EMA

EMA
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EMA committee hands down positive opinion to extend Kyprolis indication

May 30, 2016

Saxagliptin/dapagliflozin receives positive opinion in E.U.

May 30, 2016

EMA committee recommends approval of Epclusa for hepatitis C

May 30, 2016

EMA committee does not support approval of Ninlaro capsules

May 30, 2016

EMA's CHMP gives positive opinion on brentuximab vedotin for post-transplant Hodgkin's lymphoma

May 30, 2016

EMA begins review of guidelines governing first-in-human trials

May 30, 2016

Humira receives CHMP positive opinion to treat certain forms of noninfectious uveitis

May 30, 2016

Merck & Co. receives positive opinion for Zepatier in the E.U.

May 30, 2016

EMA committee recommends approval of Revestive for pediatric patients with short bowel syndrome

May 27, 2016

EMA accepts MAA for Pfizer's Trumenba

May 23, 2016
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