The EU's medicines watchdog on Friday gave the thumbs up to two new vaccines against the bluetongue virus which struck parts ...

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

If approved by the EMA, mavorixafor would be the first drug indicated for patients with WHIM syndrome in Europe, a population ...

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 ...

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

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

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

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 ...

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 ...

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