Keyword: European Medicines Agency
While the FDA gave an emergency green light to chloroquine's use against coronavirus, European regulators are restricting the drug to clinical trials.
After months of delay for ultra-pricey gene therapy Zynteglo, Bluebird Bio is hoping to dose its first German patients in the first half of the year.
After a global scare over Zantac contamination, generic metformin could be next in line as regulators test for possible carcinogen contamination.
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.