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 ...

Rising diagnoses of certain cancers in people under 50 predate the rollout of COVID-19 vaccines by decades, undermining ...

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 ...

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

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 ...

Biogen Inc. (BIIB) announced Thursday that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New ...

In a good-news-bad-news week for Biogen, the company will cut an undisclosed number of employees, just as a higher dose of ...

Pharma: Launch of Shortages Monitoring Platform, several Changes re Clinical Trial Management in EU Countries; Devices: Resolution on the need ...

The FDA has granted fast-track designation to an investigational antisense oligonucleotide to treat individuals with myotonic ...

Teva Pharmaceuticals International GmbH, a subsidiary of Teva, has entered into a strategic collaboration with Klinge Biopharma GmbH and Formycon AG for the semi-exclusive commercialization of FYB203, ...