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BioWorld - Wednesday, April 22, 2026
Home » Topics » Regulatory » EMA

EMA
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EMA grants positive opinion to Pfizer's Inlyta for kidney cancer

May 29, 2012

European CHMP recommends approval of Jentadueto

May 29, 2012

Kalydeco recommended for E.U. approval

May 29, 2012

CHMP supports monotherapy indication for Eisai's antiepileptic agent Zonegran

May 29, 2012

EMA recommends approval for AMPA receptor antagonist Fycompa

May 29, 2012

EMA validates Gilead's MAA for boosting agent cobicistat

May 24, 2012

Medtronic's Resolute Integrity stent receives approval in new indications in Europe

May 16, 2012

Arno Therapeutics product obtains orphan drug status for NF2

May 14, 2012

The EMA’s Shambolic Handling of Glybera

May 7, 2012
By Nuala Moran
If you can’t see the wood for the trees the common sense response is to do a little thinning and let the light shine through. But for the bogged-down-in-bureaucracy European Medicines Agency (EMA), the response last week to the need to increase transparency and streamline its procedures was to set up an expert committee to investigate the activities and operations of its expert committees. I don’t imagine this is a cynical move by the recently installed head of EMA, Guido Rasi, to kick complaints about a lack of transparency and failure to listen to the needs of patients into the...
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Gentium receives day 180 list from EMA for defibrotide MAA

May 7, 2012
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