FDA Accepts Cogent Biosciences' NDA For Bezuclastinib In Patients With Advanced Systemic Mastocytosis
Benzinga Newsdesk 1 month ago
BiotechGeneralNews
NDA supported by positive results from the APEX pivotal trial demonstrating clinically meaningful responses and evidence of disease modification in patients with AdvSMPDUFA target action date set for June 29, 2027
NDA supported by positive results from the APEX pivotal trial demonstrating clinically meaningful responses and evidence of disease modification in patients with AdvSM
PDUFA target action date set for June 29, 2027