Biogen’s studies of its drug for a rare ... While a trial of tofersen didn’t prove it slows ALS, the drug did decrease levels of a protein associated with brain injury. The usual approach ...

If approved, tofersen would be the first drug for a rare form of ALS, CNBC reported. In a phase 3 study, Biogen tested 108 ALS patients with superoxide dismutase 1, which is “an antioxidant ...

If approved, tofersen would be the first treatment to target a genetic cause of ALS, albeit one ... by 25 January, and Biogen will also have to make the case for its drug at an advisory committee ...

Medicare Advantage plans must cover Biogen’s (NASDAQ:BIIB) drug Qalsody for the treatment of ALS, according to a report. The U.S. Centers for Medicare & Medicaid Services has directed insurance ...

A Biogen drug that targets a rare form of ALS got partial support from a panel of US Food and Drug Administration advisers Wednesday, paving the way for a possible accelerated approval.

The Biogen drug addresses a subset of ALS patients whose disease is driven by mutations to the SOD1 gene. These mutations lead to abnormal versions of the SOD1 protein believed to contribute to ...

The Biogen drug, tofersen, is currently under priority review by the U.S. Food and Drug Administration with an approval decision expected by Jan. 25. Sign up here. ALS, also known as Lou Gehrig's ...

Biogen Inc. BIIB received a setback late Wednesday after a Food and Drug Administration advisory committee said the biotech drug maker’s proposed amyotrophic lateral sclerosis, or ALS ...

Despite the approval of Biogen Inc.’s Qalsody (tofersen) for treating amyotrophic lateral sclerosis (ALS), there are still hurdles for the drug to clear, including a confirmatory study and setting a ...

Although Biogen’s drug failed both the main and secondary ... in documents released on the agency’s website. Patients with ALS, sometimes called Lou Gehrig’s disease, are willing to accept ...

If approved, tofersen would be the first drug for a rare form of ALS, CNBC reported. In a phase 3 study, Biogen tested 108 ALS patients with superoxide dismutase 1, which is "an antioxidant enzyme ...