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BioWorld - Thursday, April 30, 2026
Home » Topics » Regulatory » EMA

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Cimzia gets positive opinion for PsA and approval for severe active axial spondyloarthritis

Oct. 29, 2013

Synflorix receives positive opinion from the EMA's CHMP for additional indication

Oct. 29, 2013

Actelion receives positive CHMP opinion for Opsumit in PAH

Oct. 29, 2013

Patient Experience Still Undervalued in Regulating Drugs

Oct. 28, 2013
By Marie Powers
As I write this, I’m sitting in the University of British Columbia/Vancouver General Hospital (UBC/VGH) Eye Care Centre, where my husband, Chuck, is completing post-tests at the conclusion of a six-month study on prosopagnosia, otherwise known as face blindness. The condition isn’t treatable with drugs – not yet, at least – but it’s nonetheless disabling, prompting researchers at several centers in North America and Europe to work collaboratively and seek to help patients carry on with their lives. Clinical studies of prosopagnosia have, so far, informed researchers more about the causes and structural manifestations of the disease than about potential...
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CHMP issues opinion on compassionate use of Gilead's sofosbuvir for chronic HCV infection

Oct. 28, 2013

EMA committee recommends approval of Lundbeck's Brintellix

Oct. 28, 2013

Defibrotide receives positive COMP opinion for prevention of GVHD

Oct. 14, 2013

FDA and EMA accept OMS-302 marketing applications for review

Oct. 3, 2013

MAA filing for naloxegol for opioid-induced constipation accepted by EMA

Sep. 30, 2013

EMA accepts olaparib MAA for review

Sep. 30, 2013
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