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 ...

Shares of Ionis Pharmaceuticals (NASDAQ:IONS) climbed 7% today after the company announced that regulatory agencies in the ...

Biogen’s applications for the higher dose regimen of SMA drug Spinraza are now under review in the US and Europe.

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 ...

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

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 ...

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

The Danish Medicines Agency requested the EMA's Pharmacovigilance Risk Assessment Committee review reports on the vision-threatening condition.

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

The FDA added a boxed warning about rare cases of anaphylaxis associated with the multiple sclerosis (MS) drug glatiramer ...