A Wicklow mother is among a concerned group of parents who are calling for individual trials of the modulator therapies for ...

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 ...

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

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

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 ...

X4 Pharmaceuticals (XFOR) announced that its Marketing Authorization Application for mavorixafor for the treatment of WHIM syndrome, a rare ...

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 ...

Submission supported by positive results from global, Phase 3 4WHIM clinical trial;U.S. regulatory approval in WHIM syndrome granted in ...

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 ...