News

The Manila Times11m
Capricor Therapeutics Provides Regulatory Update on Deramiocel BLA for Duchenne Muscular Dystrophy
FDA issued Complete Response Letter Capricor plans to resubmit its BLA to include data from the ongoing Phase 3 HOPE-3 trial ...
FDA publishes full texts of response letters to drug applications
The U.S. Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as ...
Pharmaceutical Technology40m
FDA issues more than 200 CRLs for transparency
The FDA has issued more than 200 complete response letters, which detail reasons for non-approval of drug applications.