More drugmakers are targeting incurable diseases like ALS, often forcing the FDA to grapple with difficult questions of whether to clear medicines backed by questionable data for desperate patients.

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 ...

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 ...

The Food and Drug Administration has agreed to review Biogen’s experimental drug for a rare genetic form of ALS even though the medicine failed to meet its primary goal of slowing functional ...

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 it’s ...

While the FDA uses the committee’s recommendation to decide whether or not to approve the drug, it is not bound by the decision. Biogen shares were up 0.3% after hours, following a 1.9% decline ...

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.

Biogen's studies of its drug for a rare form of ALS suggest the drug has a "treatment effect," the Food and Drug Administration's staff said.

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 ... Patients with ALS, ...