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BioWorld - Monday, May 4, 2026
Home » Topics » Regulatory » EMA

EMA
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European CHMP hands down negative opinion for Raxone MAA

Jan. 18, 2013

FDA and EMA to review GE Healthcare's applications for flutemetamol (18F)

Jan. 10, 2013

European orphan drug designation recommended for VAL-083 for glioma

Jan. 8, 2013

EMA accepts MAA for aripiprazole depot formulation

Dec. 24, 2012

Intercell obtains positive CHMP opinion for pediatric use of its JE vaccine

Dec. 20, 2012

Roche's Perjeta receives CHMP recommendation for approval

Dec. 18, 2012

Alexza's MAA for Adasuve receives positive opinion from EMA advisory committee

Dec. 18, 2012

EMA committee recommends approval of Selincro for alcohol dependence

Dec. 17, 2012

Vanda's Fanaptum receives negative opinion from EMA

Dec. 17, 2012

EMA committee adopts negative opinion on MAA for Kynamro in HoFH

Dec. 17, 2012
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