Keyword: European Medicines Agency
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.
The EMA has decided to block the API for amoxicillin trihydrate produced by a company in China whose manufacturing oversight has been lacking.
As Allergan chases a U.S. approval for uterine fibroids drug Esmya, across the pond, regulators are investigating the treatment for liver damage.
Despite a frantic effort to rush Ebola vaccines through testing during an epidemic, Merck will fall short in its goal to file its candidate this year.
With all eyes fixed on Monday's vote for the European Medicines Agency relocation, Milan and Amsterdam emerged as top picks.
With time running short, EU members have been asked to set aside parochial interests in their pick for a new city to host the EMA.