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BioWorld - Friday, April 3, 2026
Home » Topics » Regulatory » EMA

EMA
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EMA confirms that MAA for AcelRx's sublingual sufentanil can use centralized procedure

Dec. 24, 2015

EMA accepts Vanda's MAA for Fanaptum

Dec. 23, 2015

EMA CHMP recommends approval of Sanofi Pasteur MSD's hexavalent vaccine Vaxelis

Dec. 22, 2015

EMA committee supports approval of Shield's Feraccru to treat iron deficiency anemia

Dec. 22, 2015

CHMP recommends approval of Lilly's necitumumab and ramucirumab

Dec. 22, 2015

EMA committee backs approval of Brilique 60 mg for patients with history of heart attack

Dec. 21, 2015

EMA CHMP recommends approval of AstraZeneca's osimertinib for NSCLC

Dec. 21, 2015

Bayer's recombinant factor VIII BAY-81-8973 receives positive CHMP opinion

Dec. 21, 2015

EMA committee recommends approval of lesinurad for hyperuricemia in gout

Dec. 21, 2015

Committee backs E.U. orphan drug designation for axalimogene filolisbac in anal cancer

Dec. 16, 2015
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