Tag: Amylyx ALS drug

FDA, Regulations

FDA extends review of Amylyx ALS drug, delaying approval decision

June 3, 2022

Via: Biopharma Dive

The FDA doesn’t disclose its rationale for extending drug reviews and Amylyx’s statement on the delay offered few details, making it hard to tell how the agency views the company’s application. Two months ago, expert advisers convened by the FDA […]