Merck MRK and its Japanese partner Daiichi Sankyo announced that the FDA has accepted the biologics license application (BLA) ...
Patritumab deruxtecan's BLA withdrawal was due to HERTHENA-Lung02 trial's unsatisfactory overall survival results, despite progression-free survival significance. The HERTHENA-Lung02 trial compared ...
The FDA has scheduled a decision date for 10 October 2026 under the Prescription Drug User Fee Act.