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BioWorld - Saturday, May 2, 2026
Home » Topics » Regulatory » EMA

EMA
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The EMA validates PTC Therapeutics' MAA for ataluren

Dec. 10, 2012

FDA approves Cometriq, EMA accepts MAA

Nov. 30, 2012

EMA recommends granting orphan status to Aspireo's somatoprim

Nov. 26, 2012

EMA to begin formal review of macitentan MAA

Nov. 22, 2012

Zytiga receives positive CHMP recommendation for castration-resistant prostate cancer

Nov. 20, 2012

CHMP recommends Exjade approval for non-transfusion-dependent thalassemia syndromes

Nov. 20, 2012

EMA committee recommends approval of lixisenatide

Nov. 19, 2012

CHMP recommends approval of Novartis's meningococcal group B vaccine

Nov. 19, 2012

Zaltrap receives positive CHMP opinion for metastatic colorectal cancer

Nov. 19, 2012

European Commission denies marketing authorization for taliglucerase alfa

Nov. 5, 2012
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