Catalyst Pharma is suing the FDA over its approval of a potential rival to its rare disease therapy Firdapse, calling it “arbitrary, capricious, and contrary to law.”
Eisai has retreated from the optimistic view of sales growth for Alzheimer's disease drug Leqembi it held earlier this year as uptake remains sluggish.
Investigator sites are essential for successful execution of clinical trials – ensuring studies are conducted ethically, safely, and in compliance with regulatory standards.