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GSK receives positive opinion for self-injectable formulation of Benlysta for SLE

Sep. 18, 2017

EMA committee recommends approval of Trelegy Ellipta for COPD

Sep. 15, 2017

EMA grants orphan drug designation to seladelpar for primary biliary cholangitis

Sep. 12, 2017

EMA grants orphan drug designation to Vivus' tacrolimus for PAH

Sep. 7, 2017

FDA, EMA grant orphan drug designation to QRX-421 for Usher syndrome

Sep. 6, 2017

EMA validates for review MAAs for combination of binimetinib and encorafenib

Aug. 28, 2017

Tetraphase Pharmaceuticals submits marketing application for i.v. eravacycline in Europe

Aug. 18, 2017

EMA announces business continuity plan to prepare for U.K.'s withdrawal from the E.U.

Aug. 4, 2017

EMA's CHMP recommends Verkazia for severe vernal keratoconjunctivitis in children and adolescents

July 25, 2017

EMA committee recommends approval of Vimpat for focal-onset seizures in children

July 25, 2017

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