STAT+: Brainstorm to seek FDA approval for ALS stem-cell treatment, despite agency objections

Last year, the Food and Drug Administration issued a rare public statement to inform the ALS community that a negative clinical trial involving an experimental stem-cell therapy from Brainstorm Cell Therapeutics did not support the filing of a marketing application.
On Monday, Brainstorm announced its intention to seek approval from the FDA for its ALS treatment, called NurOwn, regardless of the agency’s past opposition . Continue to STAT+ to read the full story…