On April 25 Biogen and Ionis are set to find out whether the US Food and Drug Administration ("FDA") will approve their therapy Tofersen to treat patients with superoxide dismutase 1 amyotrophic ...

The Food and Drug Administration approved Tofersen, an investigational drug developed by Biogen and Ionis Pharmaceuticals, to treat a rare genetic form of amyotrophic lateral sclerosis (ALS) Tuesday ...

An FDA advisory panel voted for and against the clinical benefit of tofersen — Biogen’s investigational drug for amyotrophic lateral sclerosis, which failed to pass its primary endpoint in a ...

With QALSODY, Biogen has advanced the role of neurofilament in the development of new medicines for ALS, with the potential to accelerate further discovery in the field The CHMP’s recommendation ...

If it’s approved, the medication, tofersen, would be the first drug targeting a specific genetic cause of the incurable paralysis disease to get the regulatory green light. Biogen and its ...

Biogen BIIB announced that an FDA advisory committee gave a mostly favorable opinion on its new drug application (NDA) seeking approval for its pipeline candidate, tofersen for treating patients ...

A terminally-ill woman from Rugby has spoken out about missing out on a new drug that could help her condition.

Already struggling to make headway with its recently launched Alzheimer's drug, Biogen suffered a major late-stage pipeline setback after its tofersen drug for amyotrophic lateral sclerosis (ALS ...

On Thursday, the European Commission granted marketing authorization under exceptional circumstances and maintained orphan designation for Biogen Inc’s (NASDAQ:BIIB) Qalsody (tofersen ...

The sponsor, Biogen, and the authors designed these trials. Biogen provided tofersen and placebo, oversaw the trial, performed the statistical analyses, and paid for medical writing assistance.

The medicine in question, Biogen’s tofersen, is designed to treat a rare genetic form of the neurodegenerative disease, accounting for some 2% of all ALS cases. And the issue is how the U.K.’s ...

QALSODY is also approved for use in the United States and Biogen is engaging with regulatory authorities in other regions. About QALSODY ® (tofersen) QALSODY ® (tofersen) is an antisense ...