The new intrathecal formulation means the one-shot gene therapy is now available to all SMA patients, regardless of their age, and could free them from having to take regular, lifelong SMA treatments ...
A high-dose regimen of nusinersen (Spinraza) has been recommended for approval by the CHMP, marking a potential new option ...
Biogen Inc (BIIB) stock reached a 52-week high of 177.37 USD, marking a significant milestone for the biotechnology company. This peak reflects an 11.02% increase in its stock price over the past year ...
In November 2025, Biogen received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use recommending approval of a high dose nusinersen regimen for 5q ...
SMA is a rare, genetic neuromuscular condition that affects people across age groups. With treatment landscapes evolving ...
A CHMP panel has recommended the high-dose version’s approval, countering an FDA rejection for the drug in recent months.
The recommendation is based on the Phase II/III DEVOTE study testing the higher dose in treatment-naïve patients and those already on the low dose.
The clock is up on Biogen’s extra two years of a biosimilar-free U.S. market for its blockbuster multiple sclerosis (MS) med ...
ReCode Therapeutics, a clinical-stage genetic medicines company using tissue-specific delivery to power the next wave of mRNA and gene correction therapeutics, today announced that the U.S. Food and ...
Positive CHMP opinion is based on data from the DEVOTE study which evaluated the high dose regimen of nusinersen in treatment ...
Biogen (BIIB) announced the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a ...
Biogen has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has ...
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