BridgeBio Pharma’s NDA for Acoramidis Accepted by FDA
The U.S. FDA has accepted BridgeBio Pharma's New Drug Application for acoramidis, an investigational drug for Transthyretin Amyloid Cardiomyopathy....
Prescription Drug User Fee Act
FDA Identifies Deficiencies in Hetlioz Review
Vanda Pharmaceuticals has received a notification from the FDA regarding deficiencies in the supplemental new drug application for Hetlioz,...
Adaptimmune Therapeutics Receives FDA Priority Review for Sarcoma License Application
In a major breakthrough, Adaptimmune Therapeutics has announced that the FDA has accepted its biologics license application for priority...
Autolus Therapeutics Receives BLA Acceptance for Obecabtagene Autoleucel
The U.S. Food and Drug Administration has accepted Autolus Therapeutics' Biologics License Application for obecabtagene autoleucel, a treatment for...
FDA Accepts Karuna Therapeutics’ NDA for KarXT
The U.S. Food and Drug Administration has accepted Karuna Therapeutics' New Drug Application for KarXT xanomeline-trospium, a treatment for...