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CHMP adopts negative opinion for masitinib marketing authorization in indolent systemic mastocytosis

Sep. 18, 2017

Ontruzant becomes the first trastuzumab biosimilar to receive a positive opinion from CHMP

Sep. 18, 2017

CHMP adopts positive opinion for Zubsolv as treatment of opioid dependence

Sep. 18, 2017

Santhera receives negative opinion from CHMP for its Type II extension application for Raxone in DMD

Sep. 18, 2017

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

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