LONDON - GlaxoSmithKline PLC (LSE/NYSE: NYSE:GSK) announced today that the European Medicines Agency (EMA) has begun ...

The European Medicines Agency (EMA), which is the regulator for vaccines and medicine in the European Union (EU), has stopped ...

As users continue to leave X (formerly Twitter) en masse, many in favor of the newer Bluesky platform, the European Medicines ...

This European review of the prefilled syringe follows GSK's receipt of approval from the US Food & Drug Administration on January 8. GSK is also investigating submission of the new presentation to ...

A safety committee will review all evidence from trials and studies to shed more light on the potential risk of NAION.

Regulators in the U.S. and the European Union agreed to review Biogen’s applications for approval of a higher dose Spinraza ...

An investigational higher dose of spinal muscular atrophy drug nusinersen gains attention as the FDA and European Medicines Agency (EMA) considerate it as an alternative than the current lower ...

The safety committee of the European Medicines Agency (EMA) will again study the medication, semaglutide, out of concerns ...

Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the company has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for trofinetide for the ...

Biogen said the U.S. Food and Drug Administration has accepted its supplemental new-drug application, while the European Medicines Agency has validated its application, which confirms that the ...