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

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

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

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 ...

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

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

We are pleased to announce that our applications for the higher dose regimen of nusinersen are now under review in the US and Europe,” said Stephanie Fradette, Pharm.D., Head of the Neuromuscular ...

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 ...

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

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 ...

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