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

Spinraza (nusinersen) is a prescription drug used to treat spinal muscular atrophy. Spinraza can cause side effects that range from mild to serious. Examples include headache and fever.

Nusinersen, marketed as SPINRAZA, targets the underlying cause of SMA and has been widely used globally. The FDA acceptance and EMA validation of the supplemental New Drug Application (sNDA ...

A Boston-area biopharmaceutical firm has submitted a biologics license application to the FDA for its investigational, fully ...

Cost-effectiveness body NICE has rejected Biogen’s Spinraza (nusinersen) therapy for the rare genetic muscle wasting disease spinal muscular atrophy (SMA) because of its high cost – but is in ...

In surveys, parents of children with SMA and healthcare professionals in Sweden note the many ways the pandemic affected ...

Nusinersen is currently commercialized under the brand name SPINRAZA in over 71 countries at the label-approved dose of 12 mg. About the DEVOTE StudyDEVOTE was a Phase 2/3 randomized, controlled ...

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

Nusinersen is currently commercialized under the brand name SPINRAZA in over 71 countries at the label-approved dose of 12 mg. “Continued progress to improve upon the remarkable initial ...

compared to the approved nusinersen regimen (SPINRAZA®). “We are pleased to announce that our applications for the higher dose regimen of nusinersen are now under review in the US and Europe, ...