-
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.