ALS

The approval came despite a drug-makers' study that failed to meet the company goal of significantly slowing ALS. The drug did make a difference on lab measures of the disease, but the FDA is requiring additional research.

Patients with insurance coverage say the cost set by drugmaker Amylyx Pharmaceutical is fueling insurance delays or denials, and sometimes exorbitant out-of-pocket expenses.

A controversial new drug for ALS could add months to patients' lives – if it actually works

In March, experts who advise the FDA questioned the efficacy of an experimental new drug for ALS. In September, they voted to approve it anyway.

The ruling is a remarkable turnaround for the much-debated medication that was previously rejected by the same group this year.

The vote by the agency's health advisers is a potential setback for patient groups who have lobbied for the medication’s approval for more than a year.

On Wednesday, a panel of FDA advisers is scheduled to take a nonbinding vote on whether the drug from Amylyx Pharmaceuticals should be approved.

The agency may soon approve another drug for a deadly neurodegenerative disease based on partial data that’s being debated by experts.

Scientists who conducted the study say they couldn't determine exactly why the rate was higher but suggested that repetitive head impacts and traumatic brain injuries may play a role.

Scientists say new drugs are on the way for patients with ALS. The latest is a two-drug combo that appears to slow the progression of the fatal nerve disease with a modest but meaningful benefit.