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New Drug Application
Biotech
Cogent eyes FDA approval after clearing another ph. 3 hurdle
A combo including the company's tyrosine kinase inhibitor scored a 46% objective response rate, compared to 26% for monotherapy.
Darren Incorvaia
Nov 10, 2025 10:57am
Akeso scores twice in phase 3, tees up regulatory submission
Aug 25, 2025 1:37pm
FDA aims for September approval decision for Stealth's drug
Aug 21, 2025 10:15am
Regenxbio's Hunter gene therapy latest to face FDA delay
Aug 19, 2025 10:30am
Stealth Bio submits rare disease application for the third time
Aug 18, 2025 11:08am
Sellas’ AML asset tied to 50% response rate in certain patients
Jul 15, 2025 10:34am
