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BioWorld - Tuesday, June 16, 2026
Home » Topics » Regulatory » EMA

EMA
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Arno's AR-12 receives E.U. orphan drug status for cryptococcosis and tularemia

May 4, 2015

Astellas launches Cresemba in the U.S. for invasive aspergillosis and invasive mucormycosis

April 28, 2015

Daiichi Sankyo's edoxaban recommended for stroke prevention in Europe

April 28, 2015

EMA classifies NeoStem's NBS-20 as advanced therapeutic medicinal product

April 28, 2015

European committee recommends approval of Hetlioz for non-24-hour sleep-wake disorder

April 27, 2015

EMA committee recommends approval of Opdivo for advanced melanoma

April 27, 2015

Positive European opinion on methylnaltrexone bromide for opioid-induced constipation

April 27, 2015

Critical Path Institute's skeletal muscle safety markers supported by regulatory agencies

April 16, 2015

EMA approves compassionate use of OMS-721 in patients with aHUS

April 15, 2015

European orphan drug designation for Trappsol Cyclo transferred to MNE

April 9, 2015
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