FDA Approves High Dose Regimen of SPINRAZA(R) for Spinal Muscular Atrophy, Reflecting ...

The Muscular Dystrophy Association (MDA) celebrates today's announcement that the U.S. Food and Drug Administration (FDA) has approved a High Dose Regimen of SPINRAZA(R) (nusinersen) for the treatment ...

FDA Approves New High Dose Regimen of SPINRAZA® (nusinersen) for Spinal Muscular Atrophy

The approval was anchored on data from the pivotal DEVOTE study that investigated the efficacy and safety of the High Dose Regimen of SPINRAZA in ...
PharmaTimes

FDA approves new high dose Spinraza regimen for SMA

Kenneth Hobby, President of Cure SMA, said: “Nearly ten years ago, the approval of Spinraza marked a turning point in SMA ...

Biogen high-dose Spinraza approval seen supporting long-term growth

The US Food and Drug Administration has approved a higher-dose version of Spinraza, a key therapy from Biogen Inc ...
MPR

High Dose Spinraza Receives FDA Approval for Spinal Muscular Atrophy

This high dose nusinersen regimen for spinal muscular atrophy includes 50mg loading doses and 28mg maintenance doses.

FDA Approves High Dose Regimen of SPINRAZA for People Living with SMA

Cure SMA, the leading nonprofit organization supporting those impacted by spinal muscular atrophy (SMA), celebrates that Biogen today announced FDA approval of the High Dose regimen of SPINRAZA(TM) ...

Did FDA’s High‑Dose SPINRAZA Approval Just Shift Biogen’s (BIIB) Rare Disease ...

In late March 2026, Biogen announced that the U.S. FDA approved a new High Dose Regimen of SPINRAZA (nusinersen) for spinal muscular atrophy, allowing faster loading with two 50 mg doses and 28 mg ...
Seeking Alpha

Biogen lauds benefits of higher dose Spinraza for spinal muscular atrophy

Biogen said that new data examining its already approved spinal muscular atrophy treatment Spinraza (nusinersen) indicates that a higher dose than currently approved may lead to better improvement in ...

Biogen stock pops after FDA approves new high-dose Spinraza for spinal muscular atrophy

Biogen Inc. BIIB shares are up on Monday following the FDA’s approval of a new high-dose regimen for Spinraza (nusinersen), a ...
BioSpace

Biogen Bounces Back With FDA Nod for High-Dose Spinal Muscular Atrophy Drug

After a surprise rejection in September last year, the FDA has signed off on a high-dose formulation of Biogen’s spinal muscular atrophy drug Spinraza. The approval, announced Monday, will allow a ...
Nasdaq

Biogen Receives European Nod For High-Dose Regimen Of SPINRAZA In Spinal Muscular Atrophy

(RTTNews) - Biogen Inc. (BIIB) announced that the European Commission has granted marketing authorisation for a high-dose regimen of SPINRAZA, comprised of 50 mg/5 mL and 28 mg/5 mL doses, for 5q ...
FiercePharma

Biogen fills in some of the blanks on its trial of a high-dose version of Spinraza

A trial of Biogen’s spinal muscular atrophy (SMA) therapy Spinraza (nusinersen) suggests that a higher dose provides benefits to a broad range of patients—including those who have and have not been ...