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 ...

To get one, go to the subscriptions page. Biogen’s studies of its drug for a rare form of amyotrophic lateral sclerosis suggest the drug has a “treatment effect,” the Food and Drug ...

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 ...

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 ...

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.

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 ...

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 ...

Biogen Inc.’s studies of its drug for a rare form of amyotrophic lateral sclerosis suggest the drug has a “treatment effect,” the Food and Drug Administration’s staff said in documents ...

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 ...