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

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

Eisai Co., Ltd. (ESALF.PK) and Biogen Inc. (BIIB) announced Sunday that the U.S. Food and Drug Administration has approved the ...

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

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 ...

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 ...

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 ...

EMA recommends 114 medicines for marketing authorisation; 46 had a new active substance: Amsterdam, The Netherlands Saturday, January 18, 2025, 13:00 Hrs [IST] European Me ...

Biogen (BIIB) announced that the U.S. Food and Drug Administration, FDA, has accepted the company’s supplemental New Drug Application, sNDA, ...

A Wicklow mother is among a concerned group of parents who are calling for individual trials of the modulator therapies for their children with Cystic Fibrosis who still do not have access to these ...

If approved by the EMA, mavorixafor would be the first drug indicated for patients with WHIM syndrome in Europe, a population estimated to be approximately 1,000 people. Earlier this month X4 ...