Keyword: European Medicines Agency
Indian drugmaker Theon Pharmaceuticals has been cited for falsifying records.
If its universal flu vaccine succeeds in phase 3, BiondVax aims to hustle to the European market, CEO Ron Babecoff said.
Thursday was a busy day for Europe’s regulators—and their whirl of activity will send several drugmakers into the weekend happy.
European regulators are recommending an immediate suspension and recall of AbbVie and Biogen multiple sclerosis drug Zinbryta.
It was a short run, but Biogen and AbbVie’s multiple sclerosis-fighter Zinbryta is coming off markets around the globe.
The EMA has been probing the safety of Allergan’s Esmya since December. Now it's advising no new patients start taking it until the investigation wraps up.
Roche and Shire are taking their hemophilia battle across the pond.
After picking up key regulatory nods in the U.S., GlaxoSmithKline’s Shingrix is well on its way to expanding its reach into Europe.
Intent to focus on the first -ever gene therapy launch in the U.S., Spark Therapeutics has licensed voretigene neparvovec to Novartis in all other markets.
Novartis' Kymriah won regulatory milestones from the FDA and EMA as the company works to hold its leadership position in the budding CAR-T field.