Keyword: European Medicines Agency

Compared with the FDA "boxed warning," the EMA version puts a smaller restriction on the higher dose but broadens the cautionary language.

Bluebird Bio has overcome a manufacturing hiccup that looked like it would delay its gene therapy launch in Europe until next year.

Novartis’ Sandoz opened the floodgates with its recall of generic Zantac. Now other drugmakers are piling on—and a global recall could be looming.

Novartis’ Cosentyx is battling Lilly’s Taltz in three indications. Now, with new phase 3 data in spondyloarthritis, Novartis wants to make it four. 

Mitsubishi Tanabe’s Radicava touted its FDA approval as a win for ALS patients. But on the clinical data that backed it, the EU wants to see more.

Analysts left Bluebird's investor event with modest expectations for Zynteglo's launch in Europe, where it's on track for its first approval.

After a tough year in the competitive MS field, Sanofi’s Lemtrada could hardly afford another setback. But that’s exactly what it got.

The likely EU approval of Bluebird's gene therapy to treat transfusion-dependent β-thalassemia has renewed speculation about pricing.

The EMA initially rejected Xeljanz's application in 2013 out of safety concerns, only to change its mind in 2017.

The European Medicines Agency has found issues at the plant of an Indian API maker that the FDA hit with a warning letter some years back.